Study Assessing the Effect of Medications to Prevent Fever on Prevenar 13®

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.

Conditions

• Pneumococcal Vaccines

Interventions

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.

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.

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.

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.

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.

Sponsors & Collaborators

• Pfizer

  lead INDUSTRY

Principal Investigators

• Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

56 Days

Max Age

98 Days

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2011-08-31

Primary Completion

2013-01-31

Completion

2013-01-31

Countries

• Poland

Study Locations