Approval Probability
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Also known as Prevenar 13
Prevnar13 · 1 trial · 1 indication
Assessed solicited administration site events include injection site tenderness (administration site pain), erythema (redness), swelling and induration. Any solicited administration site events = occurrence of the event regardless of intensity grade. Rotarix was administered orally; therefore, no administration site events were analyzed.
Assessed systemic events include change in eating habits, sleepiness, vomiting, diarrhea, irritability, persistent crying, and fever, defined as body temperature greater than or equal to (≥)38.0°C/100.4°F. Any solicited systemic events = occurrence of the event regardless of intensity grade.
Rotarix was administered orally; therefore, no administration site events were analyzed.
Systemic events assessed included rash, parotid/salivary gland swelling, and fever. These systemic adverse events were recorded for 30 days following MMR and VV vaccine administration. Any solicited systemic events = occurrence of the event regardless of intensity grade.
An unsolicited AEs is an AE that is not solicited using a subject diary and that is spontaneously communicated by the parent(s)/LAR(s) who has signed the informed consent or a solicited local or systemic AE that continues beyond the solicited period after vaccination. Any = occurrence of the event regardless of the intensity grade.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and that results in disability/incapacity. An AE leading to withdrawal includes any AEs/SAEs collected and recorded from the time of the 1st receipt of study vaccines until study end which are identified as reasons for withdrawal of the participant from the study. AESIs are pre-defined (serious or non-serious) AEs of scientific and medical concern specific to the product or program which might warrant further investigation in order to characterize and understand it. MAAEs includes any AEs that required hospitalization, or an otherwise unscheduled visit to or from medical personnel for any reason, including emergency room visits.
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 60% for each of the M14459, 96217, NZ98/254, M13520 test strain. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the third vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ LLOQ is ≥ 50% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
Serum bactericidal activity is assessed using human complement (hSBA) against Neisseria meningitidis serogroup B test strains: M14459 (fHbp); 96217 (NadA); NZ98/254 (PorA P1.4); M13520 (NHBA). The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥75% for each of the M14459, 96217, NZ98/254, M13520 test strains. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
The immune response to the rMenB+OMV NZ vaccine is assessed by measuring serum bactericidal activity using hSBA against four Neisseria meningitidis serogroup B test strains: M14459 (fHbp), 96217 (NadA), NZ98/254 (PorA P1.4), and M13520 (NHBA). The composite response is defined as the percentage of participants with hSBA titers ≥ Lower Limit of Quantitation (LLOQ) across all four strains combined. The sufficiency of the immune response to rMenB+OMV NZ at one month after the 4th vaccination was to be demonstrated if the lower confidence limit for the percentage of participants achieving hSBA titers ≥ 8 (for strains M14459, NZ98/254, M13520) and ≥16 (for strain 96217) is ≥65% for all strains combined. This outcome measure evaluated immune response to the rMenB+OMV NZ vaccine only, hence it was not applicable to the Placebo+PCV group.
The immune response to PCV13 is evaluated by measuring IgG levels using electrochemiluminescence (ECL) assay. Adjusted GMCs are assessed for each of the 13 PCV13 antigens at 1 month after the third vaccination.
| Arm | Type | Description |
|---|---|---|
| MenB+PCV Group | EXPERIMENTAL | Infant participants received rMenB+OMV NZ (Bexsero) along with PCV13 (Prevnar 13), Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by rMenB+OMV NZ, PCV13, Pediarix and Hiberix on Day 121 and rMenB+OMV NZ, PCV13/PCV20, M-M-R II and Varivax on Day 301. |
| Placebo+PCV Group | PLACEBO_COMPARATOR | Infant participants received PCV13 along with placebo, Pediarix, Hiberix and Rotarix on Day 1 and Day 61 followed by PCV13, Placebo, Pediarix and Hiberix on Day 121 and PCV13/PCV20, Placebo M-M-R II and Varivax on Day 301. |
| Name | Type | Description |
|---|---|---|
| Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ) | BIOLOGICAL | Bexsero was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301. |
| Prevnar13 | BIOLOGICAL | Prevnar13 (PCV13) was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301. |
| Pediarix | BIOLOGICAL | Pediarix (DTPa-HBV-IPV) was administered intramuscularly on Day 1, Day 61, and Day 121. |
| Hiberix | BIOLOGICAL | Hiberix (Hib) was administered intramuscularly on Day 1, Day 61, and Day 121. |
| Rotarix | BIOLOGICAL | Rotarix (HRV) was administered intramuscularly on Day 1 and Day 61. |
| M-M-R II | BIOLOGICAL | M-M-R II (MMR) was administered intramuscularly on Day 301. |
| Varivax | BIOLOGICAL | Varivax (VV) was administered intramuscularly on Day 301. |
| Placebo (saline water) | BIOLOGICAL | Placebo was administered intramuscularly on Day 1, Day 61, Day 121 and Day 301. |
| Prevnar 20 | BIOLOGICAL | Prevnar 20 (PCV13) was administered intramuscularly as a booster dose on Day 301 group who have received 3 PCV13 doses before 12 months of age but have not received their fourth booster dose. |
Inclusion Criteria: All subjects must satisfy all the following criteria at study entry: * Subjects' parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the eDiary, return ...
Prevnar is a pneumococcal vaccine being studied for use in preventing infections, including meningococcal infections, hepatitis A, and rotavirus infections. It is currently in Phase 3 clinical development as an investigational product and has not been approved for these indications.
Prevnar is developed by GSK plc, a biopharmaceutical company traded on the stock exchange under the ticker GSK. The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in healthy infants and children.
Prevnar is in Phase 3 clinical development. It has completed multiple trials, including Phase 3 studies for hepatitis A and meningococcal infections, as well as a Phase 2 study for rotavirus infections. The vaccine remains investigational and is not yet approved.
Prevnar has been studied in clinical trials including NCT00197002, a Phase 3 study of a hepatitis A vaccine given with a pneumococcal vaccine in healthy children, and NCT03621670, a Phase 3 study of a meningococcal group B vaccine and 13-valent pneumococcal vaccine in healthy infants. These trials are completed.
Yes, Prevnar is also known as Prevenar 13. This alternative name is used in some clinical and commercial contexts to refer to the same 13-valent pneumococcal vaccine product being developed by GSK plc.