Approval Probability
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Also known as 13vPnC
vaccine-13vPnC · 2 trials · 2 indications
Serotype-specific IgG concentrations to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in all participants from the blood samples taken 1 month after the infant series in Cohort 1 and the last dose 13vPnC in Cohorts 2, 3, 4. GMC and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (decreased appetite, drowsiness and irritability) were recorded for 7 days after each investigational product vaccination.
Local reactions (redness, swelling, and tenderness) at the site of the investigational product injection were monitored daily for 7 days after each vaccination. Temperature were collected at bedtime daily for 7 days and at any time during the 7 days that fever is suspected. Fever is defined as temperature of greater than or equal to 38.0ºC (100.4ºF). Other systemic events (fatigue, headache, vomiting, diarrhea, muscle pain and joint pain) were recorded for 7 days after each investigational product vaccination.
An AE was any untoward medical occurrence in a study participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage.
Number of participants with NDCMCs from 1 month after the last study vaccination (13vPnC or Hib vaccine) to 6 months after the last study vaccination in Cohorts 2, 3, and 4. An NDCMC was defined as a disease or medical condition that was not identified prior to study start and was expected to be persistent or otherwise long-lasting in its effects.
An SAE was any untoward medical occurrence at any dose that resulted in death, was life-threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect or considered to be an important medical event.
Serotype-specific OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a quantitative functional OPA assay. Confidence intervals (CIs) for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers. Individual OPA assay values below the assay LLOQ (lower limit of quantification) were set at a titer of 0.5\*limit of detection (LOD \[8\]) = (titer of 4) for the purpose of calculating the OPA GMT.
Local reactions reported using an electronic diary. Redness and Swelling scaled as Any (redness present or swelling present), Mild (2.5 to 5.0 centimeters \[cm\]), Moderate (5.1 to 10.0 cm), Severe (\>10 cm). Pain at injection site scaled as Any (pain present), Mild (does not interfere with activity), Moderate (interferes with activity), Severe (prevents daily activity).
Systemic events reported using electronic diary. Fever-Any:\>=38 degrees Celsius (C), Mild (M):\>=38 to \<38.5 degrees C, Moderate(Mod):\>=38.5 to \<39 degrees C, Severe (S):\>=39 to \<=40 degrees C, Potentially life threatening:\>40 degrees C. Headache, fatigue, muscle pain, joint pain- Any: present, M:did not interfere with activity, Mod:some interference, S:activity prevented. Vomiting- Any:present, M:1-2 times/day (d), Mod:\>2/d, S:required intravenous hydration. Diarrhoea- Any:present, M:2-3 loose stools/d, Mod:4-5/d, S:\>=6/d. All reports of fever \>40 degrees C were confirmed as data entry errors.
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between vaccination and up to 1 month (28 to 42 days) after vaccination that were absent before treatment or that worsened relative to pre-treatment state.
| Arm | Type | Description |
|---|---|---|
| 13-valent Pneumococcal Conjugate Vaccine (13vPnC) | EXPERIMENTAL | 1. Participants in cohort 1 will receive each dose of 13vPnC in months 2, 4 and 6, and then a booster dose during months 12-15. 2. Participants in cohort 2 will receive first dose dose 13vPnC at the age of months 7(included) to months 12 (less than months 12), and the second dose will be given at least 28 days after first dose, and the third dose will be months 12 to 15 (and at least 56 days after the second dose). 3. Participants in cohort 3 will receive the first dose of 13vPnC during 1 (included) to 2 years (less than 2 years of age) of age, and the second dose will be given at least 56 days after first dose. 4. Participants in cohort 4 will receive only one dose at the age of 2 (included) to 6 (less than 6 years of age) years of age. |
| Haemophilus influenzae type b (Hib) | ACTIVE_COMPARATOR | 1. No participants in cohort 1 will receive Hib vaccine. 2. Participants in cohort 2 will receive the first dose of Hib vaccine at the age of months 7 (included) to 12 (less than 12 months), and the second dose will be given at least 28 days after the first dose, the third dose will following local practice or national recommendation at the discretion of the investigator. 3. Participants in cohorts 3 and 4 will receive the only one dose Hib vaccine at the age of 1 (included) to 6 (less than 6 years) years of age. |
| Group 1 | EXPERIMENTAL | =\> 65 years of age |
| Group 2 | EXPERIMENTAL | 50 to 64 years of age |
| Name | Type | Description |
|---|---|---|
| 13vPnC | BIOLOGICAL | suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose |
| Hib | BIOLOGICAL | suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose |
| vaccine-13vPnC | BIOLOGICAL | Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1) |
Inclusion Criteria: * Evidence of a personally signed and dated ICD indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study. * Aged 6 weeks (42 days) to \<6 years at the time of consent. * Healthy infants and children as determined by medical history, ph...
13vPnC is an investigational 13-valent pneumococcal conjugate vaccine being studied for the prevention of pneumococcal disease and pneumococcal infections. It is being evaluated in healthy adults, children, and infants across multiple Phase 3 clinical trials.
13vPnC is being developed by Pfizer, Inc. (NYSE: PFE). The company is conducting clinical trials to evaluate the vaccine's safety and immunogenicity in various populations, including healthy adults aged 50 years and older, children, and infants.
13vPnC is in Phase 3 clinical development. It is an investigational vaccine and has not been approved by regulatory authorities. All completed trials for 13vPnC are Phase 3 studies, with no active trials currently ongoing.
13vPnC has been studied in four completed Phase 3 trials: NCT00562354 in healthy Japanese adults aged 50 years and older, NCT00824655 in healthy children in Sweden, NCT01432262 in adults aged 50 years and older in Mexico, and NCT03574389 in healthy Chinese infants and young children.
13vPnC is a 13-valent pneumococcal conjugate vaccine, which is the same valency as Pfizer's licensed pneumococcal conjugate vaccine. However, the data provided does not specify whether 13vPnC is the same product as Prevnar 13 or a distinct investigational candidate.