Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13® - Full Text View

Purpose

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.

Condition	Intervention	Phase
Pneumococcal Vaccines	Biological: 13-valent pneumococcal conjugate vaccine Biological: INFANRIX hexa Drug: Paracetamol Drug: Ibuprofen	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
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

Resource links provided by NLM:

MedlinePlus related topics: Fever

Drug Information available for: Acetaminophen Ibuprofen Ibuprofen sodium Ibuprofen lysinate Boostrix Heptavalent pneumococcal conjugate vaccine Adacel Pneumococcal Vaccines

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

The serotype specific IgG geometric mean concentrations (GMCs) for each of the pneumococcal serotypes measured 1 month after the infant series. [ Time Frame: Visit 4 (5 months) ] [ Designated as safety issue: No ]
The incidence of fever in the 4 days after each vaccination. [ Time Frame: Visit 1 (2 months) to Visit 6 (13 months) ] [ Designated as safety issue: Yes ]
The incidence of adverse events. [ Time Frame: Visit 1 (2 months) to Visit 6 (13 months) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The proportion of subjects achieving a serotype specific IgG antibody concentration ≥0.35 mcg/mL for each of the pneumococcal serotypes measured 1 month after the infant series. [ Time Frame: Visit 4 (5 months) ] [ Designated as safety issue: No ]
The serotype specific IgG geometric mean concentrations (GMCs) for each of the pneumococcal serotypes measured 1 month after the toddler dose. [ Time Frame: Visit 6 (13 months) ] [ Designated as safety issue: No ]
The proportion of subjects in a subset achieving a serotype specific OPA ≥lower limit of quantitation (LLOQ) for each of the pneumococcal serotypes measured 1 month after the infant series. [ Time Frame: Visit 4 (5 months) ] [ Designated as safety issue: No ]
The serotype specific OPA GMTs for each of the pneumococcal serotypes measured one month after the infant series. [ Time Frame: Visit 4 (5 months) ] [ Designated as safety issue: No ]
The geometric mean antibody concentrations/titers for the concomitant antigens contained in INFANRIX hexa measured 1 month after the infant series and 1 month after the toddler dose. [ Time Frame: Visit 4 (5 months) & Visit 6 (13 months) ] [ Designated as safety issue: No ]
The proportion of subjects achieving the prespecified criteria for the concomitant antigens contained in INFANRIX hexa measured 1 month after the infant series and 1 month after the toddler dose. [ Time Frame: Visit 4 (5 months) & Visit 6 (13 months) ] [ Designated as safety issue: No ]

Enrollment:	908
Study Start Date:	August 2011
Study Completion Date:	January 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Biological: INFANRIX hexa INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Drug: Paracetamol Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Biological: INFANRIX hexa INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Drug: Ibuprofen Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Biological: INFANRIX hexa INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Drug: Paracetamol Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Biological: INFANRIX hexa INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Drug: Ibuprofen Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
Experimental: 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.	Biological: 13-valent pneumococcal conjugate vaccine 13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age. Biological: INFANRIX hexa INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.

Eligibility

Ages Eligible for Study:	56 Days to 98 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392378

Locations

Poland
Gabinet Lekarski
Debica, Poland, 39-200
Hanna Czajka Indywidualna Praktyka Lekarska
Krakow, Poland, 31-302
NZOZ "Praktimed" sp. z o.o.
Krakow, Poland, 31-422
NZOZ Salmed
Leczna, Poland, 21-010
Specjalistyczna Praktyka Lekarska Gravita
Lodz, Poland, 91-347
SP ZOZ Lubartow
Lubartow, Poland, 21-100
NZOZ Praktyka Lekarza Rodzinnego Eskulap
Lublin, Poland, 20-044
NZOZ Praktyka Lekarza Rodzinnego Alina Grocka-Wlazlak
Oborniki Slaskie, Poland, 55-120
Specjalistyczny ZOZ nad Matka i Dzieckiem, Oddzial Obserwacyjno Zakazny A, Szpital Dzieciecy
Poznan, Poland, 61-734
NZLA Michalkowice Jarosz i Partnerzy
Siemianowice Slaskie, Poland, 41-103
NZOZ Nasz Lekarz
Torun, Poland, 87-100
Szpital im. Sw. Jadwigi Slaskiej, Oddzia Pediatryczny
Trzebnica, Poland, 55-100
DEN-MED Gabinet Lekarsko-Stomatologiczny Joanna i Jacek Witwiccy
Warszawa, Poland, 02-127
Samodzielny Publiczny Szpital Kliniczny nr 1 we Wroclawiu
Wroclaw, Poland, 50-345

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer
ClinicalTrials.gov Identifier:	NCT01392378 History of Changes
Other Study ID Numbers:	B1851047, 6096A1-4027
Study First Received:	July 8, 2011
Last Updated:	February 15, 2013
Health Authority:	Poland: Ministry of Health and Social Welfare. Poland: Research Ethics Committee.

Keywords provided by Pfizer:

Prevenar 13
13vPnC
Antipyretic medication
Healthy subjects

Additional relevant MeSH terms:

Acetaminophen
Antipyretics
Ibuprofen
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Central Nervous System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013