Skip to main content
OpenTrials
Completed

NCT Number: NCT00370318

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Infections, Rotavirus Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Pneumococcal Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Streptococcal Infections Virus Diseases

Age range

9 week–16 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GSK Investigational Site, Brno, Czechia

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

10 valent pneumococcal conjugate vaccine

Biological

Infanrix hexa

Biological

Rotarix

Biological

Paracetamol

Drug

Other names: Rotarix, Infanrix Hexa, 10 valent pneumococcal conjugate vaccine

Primary outcomes

  1. Occurrence of fever > or = to 38°C (rectal temperature)

Secondary outcomes

  1. Safety, reactogenicity and immunogenicity pre and post-vaccination

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Multicentre Study to Assess the Effect of Prophylactic Antipyretic Treatment on the Rate of Febrile Reactions Following Concomitant Administration of GSK Biologicals' 10-valent Pneumococcal Conjugate, Infanrix Hexa and Rotarix Vaccines

Important dates

Study start
2006
Study completion
2007
First posted
Aug 31, 2006
Registry last updated
Mar 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.