Clinical trial NCT01392378: Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumococcal Vaccines
Keywords: Prevenar 13
13vPnC
Antipyretic medication
Healthy subjects
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 908
Sex: ALL
Minimum age (years): 56
Maximum age (years): 98
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
Secondary outcomes:
measure: 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
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: 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
timeFrame: 1 month after the infant series
measure: Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
timeFrame: 1 month after the infant series
measure: Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
timeFrame: 1 month after the toddler dose
measure: Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
timeFrame: Within 4 days after infant series Dose 1
measure: Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
timeFrame: Within 4 days after infant series Dose 2
measure: Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
timeFrame: Within 4 days after infant series Dose 3
measure: Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
timeFrame: Within 4 days after toddler dose
measure: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
timeFrame: Baseline up to 1 Month (28 to 42 days) after infant series
measure: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
timeFrame: 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose
measure: Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
timeFrame: Toddler dose up to 1 Month (28 to 42 days) after toddler dose
Other outcomes:
Locations:
city: Debica
country: Poland
facility: Gabinet Lekarski
city: Krakow
country: Poland
facility: Hanna Czajka Indywidualna Praktyka Lekarska
city: Krakow
country: Poland
facility: NZOZ "Praktimed" sp. z o.o.
city: Leczna
country: Poland
facility: NZOZ Salmed
city: Lodz
country: Poland
facility: Specjalistyczna Praktyka Lekarska Gravita
city: Lubartow
country: Poland
facility: SP ZOZ Lubartow
city: Lublin
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Eskulap
city: Oborniki Slaskie
country: Poland
facility: NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
city: Poznan
country: Poland
facility: Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy
city: Siemianowice Slaskie
country: Poland
facility: NZLA Michalkowice Jarosz i Partnerzy
city: Torun
country: Poland
facility: NZOZ Nasz Lekarz
city: Trzebnica
country: Poland
facility: Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny
city: Warszawa
country: Poland
facility: DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy
city: Wroclaw
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Wysocki J, Center KJ, Brzostek J, Majda-Stanislawska E, Szymanski H, Szenborn L, Czajka H, Hasiec B, Dziduch J, Jackowska T, Witor A, Kopinska E, Konior R, Giardina PC, Sundaraiyer V, Patterson S, Gruber WC, Scott DA, Gurtman A. A randomized study of fever prophylaxis and the immunogenicity of routine pediatric vaccinations. Vaccine. 2017 Apr 4;35(15):1926-1935. doi: 10.1016/j.vaccine.2017.02.035. Epub 2017 Mar 3.