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

Pfizer

Status and phase: Completed; Phase 4

Conditions: Pneumococcal Vaccines

Treatments: Biological: 13-valent pneumococcal conjugate vaccine; Biological: INFANRIX hexa; Drug: Ibuprofen; Drug: Paracetamol

Study type: Interventional

Funder types: Industry

Identifiers

NCT01392378

B1851047

6096A1-4027

Details and patient eligibility

About

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.

Enrollment: 908 patients

Sex: All

Ages: 56 to 98 days old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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908 participants in 5 patient groups

Group 1

Experimental group

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Drug: Paracetamol

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Drug: Paracetamol

Group 2

Experimental group

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Drug: Ibuprofen

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Drug: Ibuprofen

Group 3

Experimental group

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Drug: Paracetamol

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Drug: Paracetamol

Group 4

Experimental group

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Drug: Ibuprofen

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Drug: Ibuprofen

Group 5

Experimental group

Description:

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.

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: 13-valent pneumococcal conjugate vaccine

Biological: INFANRIX hexa

Biological: INFANRIX hexa