Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Tritanrix™-HepB, Tritanrix-HepB, Tritanrix™- HepB, Tritanrix- HepB
Tritanrix-HepB/Hib · 8 trials · 7 indications
Pre-defined assay cut-off values for assessed titers were greater than or equal to (≥) 1:128.
Antibody cut-offs were higher than or equal to (≥) 1:128
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128.
Pre-defined assay cut-off value for assessed titers was greater than or equal to (≥) 1:128. Note: For the MenA antibodies with assay on SBA, additional testing were done using a serogroup A strain 3125 (L10 immunotype).
Antibody concentrations cut-off value was ≥ 1 microgram per milliliter (µg/mL).
Seroprotection status (SP) defined vaccinated subjects with antibody concentrations greater than or equal to (≥) 0.1 international units per millitre (IU/mL) as assessed by the Enzyme-linked Immunosorbent Assay (ELISA) or ≥ 0.016 IU/mL by neautralization assay on Vero cells in subjects seronegative for ELISA.
Among solicited general symptoms fever \[defined as rectal temperature equal to or above (≥) 38 degrees Celsius (°C )\] was assessed, post vaccination. Grade 3 fever = fever \> 39.0 °C.
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month after the PRP challenge.
The number of subjects with anti-PRP antibody concentrations equal to or above (≥) 0.15 μg/mL and ≥ 1.0 μg/mL, at one month post-booster vaccination.
A seroprotected subject was defined as a vaccinated subject, with anti-D and anti-T antibody concentrations equal to or above (≥) 0.1 International Units per milliliter (IU/mL).
The seroprotection rate is defined as the estimated proportion of subjects with protective antibodies as assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) (antibody concentration ≥ 0.1 IU/mL), or by Vero-cell neutralisation assay (antibody concentration ≥ 0.016 IU/mL), for subjects seronegative as assessed by ELISA.
A seroprotected subject was defined as a vaccinated subject with an anti-HBs antibody concentration equal to or above (≥) 10 milli International Units per milliliter (mIU/mL).
A seroprotected subject was defined as a vaccinated subject with an anti-BPT antibody concentration equal to or above (≥) 15 ELISA units per milliliter (EL.U/mL).
The booster response was defined as: * an anti-BPT antibody concentration equal to or above (≥) the cut-off value (15 EL.U/mL) at post-booster vaccination in subjects seronegative (anti-BPT antibody concentration \< 15 EL.U/mL) prior to administration of the booster dose; or * at least a 2-fold increase in antibody concentration from pre- to post-vaccination time points, in subjects who were seropositive (anti-BPT antibody concentration ≥ 15 EL.U/mL) prior to the administration of the booster dose.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Anti-PRP antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in microgram per milliliter (μg/mL), as assessed by ELISA.
Anti-D and anti-T antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in International Units per milliliter (IU/mL), as assessed by ELISA.
Anti-HBs antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in milli International Units per milliliter (mIU/mL), as assessed by ELISA.
Anti-BPT antibody concentrations are presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U/mL), as assessed by ELISA.
| Arm | Type | Description |
|---|---|---|
| AC primed Group | EXPERIMENTAL | - |
| AC unprimed Group | ACTIVE_COMPARATOR | - |
| TRITANRIX™-HEPB/HIB-MENAC +MENCEVAX™ ACWY GROUP | EXPERIMENTAL | Subjects previously primed with 3 doses of Tritanrix™-HepB/Hib-MenAC vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one booster dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| TRITANRIX™-HEPB/HIBERIX™+MENCEVAX™ ACWY GROUP | ACTIVE_COMPARATOR | Subjects previously primed with 3 doses Tritanrix™-HepB/Hiberix™ vaccine in study NCT00290303, were administered in the current study one booster dose of Tritanrix™-HepB/Hiberix™, intramuscularly in the left anterolateral thigh, at 15-24 months of age and one dose of Mencevax™ ACWY by subcutaneous injection in the upper region of the left arm, at 24-30 months of age. |
| ACAC GROUP | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccines at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. |
| ACHibPS GROUP | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with MenAC-TT vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibACPS GROUP | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibHibPS GROUP | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm. |
| CC GROUP | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix + Meningitec vaccine in the primary study (NCT00317161) are boosted in the current study with one dose of the same vaccine at 15 to 24 months of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age. |
| Tritanrix™-HepB+Rotarix™ Group | EXPERIMENTAL | Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. |
| Tritanrix™-HepB+Placebo Group | EXPERIMENTAL | Subjects received 3 doses of Tritanrix™-HepB vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. |
| Zilbrix™+Rotarix™ Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Rotarix™ vaccine at 3 and 4.5 months of age. |
| Zilbrix™+Placebo Group | ACTIVE_COMPARATOR | Subjects received 3 doses of Zilbrix™ vaccine at 3, 4.5 and 6 months of age, intramuscularly into the right anterolateral thigh concomitantly with 2 oral doses of Placebo for Rotarix™ vaccine at 3 and 4.5 months of age. |
| Triple Antigen™+Engerix™-B Group | ACTIVE_COMPARATOR | Subjects received 3 separate doses of Triple Antigen™ and Engerix™-B vaccines at 3, 4.5 and 6 months of age, intramuscularly into the left and right anterolateral thighs, respectively. |
| ACAC_Thailand Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study ( NCT00317187) are boosted in the current study with one dose of the same vaccines at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| ACHibPS_Thailand Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibACPS_Thailand Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibHibPS_Thailand Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317187) are boosted in the current study with one dose of the same vaccine at 15 to 24 months (Thailand) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| ACAC_Philippines Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccines at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. No Mencevax ACWY vaccine at 24 to 30 months of age |
| ACHibPS_Philippines Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-Hepb co-administrated with Hib-MenAC-TT vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Tritanrix-HepB/Hiberix at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibACPS_Philippines Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of Trianrix-Hepb co-administrated with Hib-MenAC-TT vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| HibHibPS_Philippines Group | EXPERIMENTAL | Subjects vaccinated with 3 doses of Tritanrix-HepB/Hiberix vaccine in the primary study (NCT00317135) are boosted in the current study with one dose of the same vaccine at 15 to 18 months (Philippines) of age, intramuscularly into the anterolateral quadrant of the left thigh or upper region of the left arm. Subjects are also administered one booster dose of Mencevax ACWY vaccine at 24 to 30 months of age by deep subcutaneous injection in the upper region of the left arm |
| Tritanrix-HepB/Hiberix Kft. Mix Group | EXPERIMENTAL | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| Tritanrix-HepB/Hiberix Kft. Ref Group | EXPERIMENTAL | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| HB Tritanrix-HepB/Hiberix Kft. Mix Group | EXPERIMENTAL | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine (with HepB at birth), received a booster dose of Tritanrix™-HepB/Hiberix™ Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| Tritanrix-HepB Kft.+Hiberix Group | EXPERIMENTAL | Healthy male and female infants who were primed with Tritanrix™-HepB Kft. and Hiberix™ vaccines, were boosted with Tritanrix™-HepB Kft. vaccine administered intramuscularly into the right upper thigh and Hiberix™ vaccine, administered intramuscularly into the left upper thigh, at 15-18 months of age. |
| PRP Tritanrix-HepB Kft. Mix Group | EXPERIMENTAL | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ Kft. vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| PRP Tritanrix-HepB Kft. Ref Group | EXPERIMENTAL | Healthy male and female infants who were primed with Tritanrix™-HepB/Hiberix™ vaccine, received plain Polyribosil-Ribitol-Phosphate (PRP) polysaccharide vaccine administered intramuscularly into the right upper thigh, at 10 months of age, followed by a booster dose of Tritanrix™-HepB Kft. administered intramuscularly into the right upper thigh, at 15-18 months of age. |
| Hib-MenAC Lot 1 Group | EXPERIMENTAL | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 1 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
| Hib-MenAC Lot 2 Group | EXPERIMENTAL | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 2 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
| Hib-MenAC Lot 3 Group | EXPERIMENTAL | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB combined vaccine mixed extemporaneously with Meningitec conjugate vaccine Lot 3 at 2, 4 and 6 months of age as an intramuscular injections in the anterolateral part of the left thigh. |
| Hiberix Group | ACTIVE_COMPARATOR | Healthy male or female subjects aged 56 to 83 days of age at the time of the first study vaccine dose, with previous hepatitis B vaccine at birth, received Tritanrix-HepB vaccine mixed extemporaneously with conjugate vaccine Hiberix at 2, 4 and 6 months of age as intramuscular injection in the anterolateral part of the thigh. |
| Name | Type | Description |
|---|---|---|
| Tritanrix™- HepB | BIOLOGICAL | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
| Hiberix™ | BIOLOGICAL | One intramuscular dose during the booster vaccination study in subjects aged 15 to 18 months |
| Mencevax™ ACW | BIOLOGICAL | One subcutaneous dose during the booster vaccination study in subjects aged 24 to 30 months |
| Mencevax™ ACWY | BIOLOGICAL | One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months |
| Tritanrix-HepB/Hib-MenAC | BIOLOGICAL | Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Haemophilus influenzae Type b meningococcal AC-tetanus toxoid conjugate Vaccine |
| Mencevax ACWY | BIOLOGICAL | GSK Biologicals' Meningococcal serogroups A, C, W135 and Y polysaccharide vaccine |
| Tritanrix-HepB/Hiberix | BIOLOGICAL | Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B Vaccine, Haemophilus influenzae type b conjugate vaccine |
| Meningitec | BIOLOGICAL | Wyeth's MenC CRM197 conjugated vaccine, Meningitec |
| Tritanrix™-HepB | BIOLOGICAL | GSK Biologicals' combined diphtheria-tetanus-whole cell Bordetella pertussis -hepatitis B vaccine. |
| Rotarix™ | BIOLOGICAL | GSK Biologicals' live attenuated human rotavirus vaccine |
| Zilbrix™ | BIOLOGICAL | GSK Biologicals Kft's combined diphtheria-tetanus whole-cell B. pertussis-hepatitis B vaccine |
| Triple Antigen™ | BIOLOGICAL | Commonwealth Serum Laboratory's (CSL's) combined diphtheria-tetanus-whole cell B. pertussis vaccine. |
| Engerix™-B | BIOLOGICAL | GSK Biologicals' hepatitis B vaccine |
| Placebo | DRUG | Placebo for the Rotarix™ vaccine |
| Mencevax-ACWY | BIOLOGICAL | Meningococcal Serogroups A, C, W-135 and Y Vaccine |
| Tritanrix™-HepB/Hiberix™ Kft. | BIOLOGICAL | GlaxoSmithKline (GSK) Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria (D), tetanus (T), whole cell Bordetella pertussis (Pw), hepatitis B vaccine with new sources of D, T and Pw antigens mixed with Haemophilus influenzae type b (Hib2.5) vaccine. |
| Tritanrix™-HepB/Hiberix™ | BIOLOGICAL | GSK Biologicals' combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B and Haemophilus Influenzae type b vaccine |
| Polyribosil-Ribitol-Phosphate (PRP) vaccine | BIOLOGICAL | plain PRP polysaccharide vaccine |
| Tritanrix™-HepB Kft | BIOLOGICAL | GSK Biologicals Korlatolt Felelossegu Tarsasag \[Kft\] (Limited Company) combined diphtheria, tetanus, whole cell Bordetella pertussis, hepatitis B vaccine with new sources of D, T and Pw antigens produced at GSK Biologicals Kft., Gödöllö, Hungary. |
| Tritanrix-HepB/Meningitec conjugate vaccine | BIOLOGICAL | The full content of two monodose vials of Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Meningitec (5/5/5) vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): one dose of 0.5 ml of the reconstituted Tritanrix- HepB/Meningitec vaccine was withdrawn from the vial and administered, the needle was changed before injection |
| Tritanrix/Hiberix vaccine | BIOLOGICAL | The full content of the Tritanrix-HepB vaccine vial was extracted and injected into the vial containing the lyophilized Hiberix vaccine. The vial was agitated until the lyophilized vaccine pellet had completely dissolved. The reconstituted mixed vaccines were used promptly after reconstitution (within 30 minutes): the full volume of the mixed vaccines was withdrawn from the vial, the needle was changed before injection. |
Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 15 and 18 months of age at the time of vaccination. * Written informed consent obtained from the parent or ...
Tritanrix-HepB is a vaccine used for the prevention of diphtheria, hepatitis B, whole cell pertussis, and infections caused by Haemophilus influenzae type b and Neisseria meningitidis. It is being developed by GSK plc for use in infants and children, with clinical trials conducted in Thailand, the Philippines, and South Africa.
Tritanrix-HepB is developed by GSK plc, a global biopharma company listed on the stock exchange under the ticker GSK. The vaccine is currently in Phase 3 clinical development for the prevention of diphtheria, hepatitis B, whole cell pertussis, and meningococcal infections.
Tritanrix-HepB is in Phase 3 clinical development. It is an investigational vaccine and has not yet been approved by regulatory authorities. All four completed Phase 3 trials have finished, with a total enrollment of 2,160 participants across studies in Thailand, the Philippines, and South Africa.
Tritanrix-HepB has completed four Phase 3 clinical trials: NCT00136604, NCT00169442, NCT00228917, and NCT00317109. These studies evaluated immune responses, safety, and booster doses of the vaccine in infants and children, with enrollment ranging from 168 to 798 participants per trial.
No, Tritanrix-HepB is not a monoclonal antibody. Although its modality is listed as monoclonal antibody in some databases, it is actually a combination vaccine designed to protect against multiple infectious diseases, including diphtheria, hepatitis B, and whole cell pertussis.
Tritanrix-HepB works by stimulating the immune system to produce antibodies against the bacteria and viruses that cause diphtheria, hepatitis B, pertussis, and Haemophilus influenzae type b infections. It is a combination vaccine that provides protection against these diseases through active immunization.