Phase 4
N=908
Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Pneumococcal Vaccines
Bottom Line
View on ClinicalTrials.gov: NCT01392378 ↗Enrolled (actual)
908
Serious AEs
3.6%
Results posted
Feb 2014
Primary outcome: Primary: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series — 1.64; 1.99; 1.48; 2.07 microgram per milliliter (mcg/mL) — p=0.0856
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- 13-valent pneumococcal conjugate vaccine (Biological); INFANRIX hexa (Biological); Paracetamol (Drug); Ibuprofen (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series |
1.64; 1.99; 1.48; 2.07; 2.02; 0.68 | 0.0856 |
| SECONDARY 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 |
96.4; 97.4; 96.6; 97.3; 98.1; 72.8 | — |
| SECONDARY Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose |
3.07; 3.43; 2.97; 3.43; 3.10; 6.70 | 0.9350 |
| SECONDARY 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 |
100.0; 100.0; 100.0; 100.0; 100.0; 94.4 | — |
| SECONDARY Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series |
1269; 1135; 1240; 1361; 1086; 794 | 0.7148 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series |
0.54; 0.59; 0.49; 0.51; 0.58 | 0.813 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series |
40.86; 43.51; 40.27; 39.26; 44.85; 46.29 | 0.712 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series |
0.73; 0.70; 0.69; 0.60; 0.82; 0.62 | 0.712 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series |
756.42; 770.93; 689.34; 599.12; 733.29 | 0.850 |
| SECONDARY Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series |
68.11; 66.59; 67.43; 70.66; 72.02; 79.60 | 0.813 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose |
9.65; 9.35; 8.25; 7.84; 8.96 | 0.910 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose |
77.43; 76.93; 73.72; 73.38; 74.01; 115.55 | 0.910 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose |
2.54; 2.50; 2.60; 2.29; 2.66; 1.64 | 0.910 |
| SECONDARY Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose |
4868.61; 4148.04; 4250.41; 4263.28; 3866.37 | 0.869 |
| SECONDARY Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose |
399.56; 426.63; 443.97; 415.45; 406.37; 613.18 | 0.910 |
| SECONDARY Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series |
87.5; 84.2; 86.1; 85.6; 87.9; 33.8 | — |
| SECONDARY Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose |
100.0; 99.3; 100.0; 100.0; 100.0; 95.2 | — |
| SECONDARY Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 |
32.9; 45.2; 18.4; 34.2; 41.7; 1.4 | — |
| SECONDARY Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 |
26.2; 42.8; 21.4; 44.0; 39.8; 1.5 | — |
| SECONDARY Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 |
22.1; 30.8; 17.0; 33.3; 29.7; 1.6 | — |
| SECONDARY Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose |
31.6; 37.1; 37.3; 50.0; 30.2; 5.5 | — |
| SECONDARY Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series |
57; 71; 67; 72; 80; 7 | — |
| SECONDARY Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series |
3; 6; 3; 4; 8; 6 | — |
| SECONDARY Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose |
47; 57; 52; 76; 50; 3 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01392378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.