Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00158756 | Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants | PHASE3 | COMPLETED | 308 | — | — | Sep 12, 2005 | Nov 23, 2006 | Jun 6, 2018 | 9 | Russia |
| NCT00317187 | Safety Study of a Vaccine Against Meningitis in Infants (2,4 & 6 Months Age) After a Birth Dose of Hepatitis B. | PHASE3 | COMPLETED | 500 | — | — | Jun 8, 2004 | Jan 16, 2005 | Aug 15, 2018 | 1 | Thailand |
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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 | 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 |
| 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 parent/guardian can and will comply with the requirements of the protocol. * Administration of one dose of hepatitis B vaccine at birth. * A male or female between, and including, 11 and 17 weeks of age at the time of the first...