A Phase 4, Randomized, Open-Label Trial To Assess The Impact Of Prophylactic Antipyretic Medication On The Immunogenicity Of 13-Valent Pneumococcal Conjugate Vaccine Given With Routine Pediatric Vaccinations In Healthy Infants
Overview
- Phase
- Phase 4
- Intervention
- 13-valent pneumococcal conjugate vaccine
- Conditions
- Pneumococcal Vaccines
- Sponsor
- Pfizer
- Enrollment
- 908
- Locations
- 14
- Primary Endpoint
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 2 months (56 to 98 days) at time of enrollment.
- •Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion Criteria
- •Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines.
- •A previous anaphylactic reaction to any vaccine or vaccine-related component.
- •Allergy or contraindication to paracetamol or ibuprofen administration.
- •Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
Arms & Interventions
Group 1
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
Intervention: 13-valent pneumococcal conjugate vaccine
Group 1
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
Intervention: INFANRIX hexa
Group 1
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of paracetamol on the day of each vaccination.
Intervention: Paracetamol
Group 2
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
Intervention: 13-valent pneumococcal conjugate vaccine
Group 2
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
Intervention: INFANRIX hexa
Group 2
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 2 doses of ibuprofen on the day of each vaccination.the first dose.
Intervention: Ibuprofen
Group 3
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
Intervention: 13-valent pneumococcal conjugate vaccine
Group 3
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
Intervention: INFANRIX hexa
Group 3
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of paracetamol on the day of each vaccination.
Intervention: Paracetamol
Group 4
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
Intervention: 13-valent pneumococcal conjugate vaccine
Group 4
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
Intervention: INFANRIX hexa
Group 4
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. They will also receive 3 doses of ibuprofen on the day of each vaccination.
Intervention: Ibuprofen
Group 5
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.
Intervention: 13-valent pneumococcal conjugate vaccine
Group 5
Subjects will receive 13-valent pneumococcal vaccine and INFANRIX hexa at 2, 3, 4 and 12 months of age. This group does not receive any antipyretic medication as part of the study.
Intervention: INFANRIX hexa
Outcomes
Primary Outcomes
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Time Frame: 1 month after the infant series
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Secondary Outcomes
- Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose(1 month after the toddler dose)
- Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series(1 month after the infant series)
- Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose(1 month after the toddler dose)
- Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose(1 month after the toddler dose)
- Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose(1 month after the toddler dose)
- Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose(1 month after the toddler dose)
- Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2(Within 4 days after infant series Dose 2)
- Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series(Baseline up to 1 Month (28 to 42 days) after infant series)
- Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series(1 month after the infant series)
- Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose(1 month after the toddler dose)
- Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose(1 month after the toddler dose)
- Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3(Within 4 days after infant series Dose 3)
- Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series(1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose)
- Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose(Toddler dose up to 1 Month (28 to 42 days) after toddler dose)
- Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series(1 month after the infant series)
- Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1(Within 4 days after infant series Dose 1)
- Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose(Within 4 days after toddler dose)