Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines

GlaxoSmithKline (GSK)

Status and phase

Completed

Phase 3

Conditions

Infections, Rotavirus

Treatments

Biological: 10 valent pneumococcal conjugate vaccine

Biological: Infanrix Hexa

Biological: Rotarix

Drug: Paracetamol

Study type

Interventional

Funder types

Industry

Identifiers

NCT00370318

107017

Details and patient eligibility

About

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically.

Full description

2 groups (200 per group); control group receives no prophylactic antipyretic treatment.

Sex

All

Ages

9 to 16 weeks old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.

Exclusion criteria

Body weight < 4.5 kg
Children having received or planning to receive any investigational or non-registered products, vaccines not foreseen in the protocol, and immune modifying drugs
Children with any disease that affects the immune system or gastro-intestinal tract
Children with a history of seizures, allergic disease, or disease(s) covered by the vaccines
Children with contraindication to paracetamol treatment.