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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-04-30

Brief Summary

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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.

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Detailed Description

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

Conditions

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Infections, Rotavirus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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10 valent pneumococcal conjugate vaccine

Intervention Type BIOLOGICAL

Infanrix Hexa

Intervention Type BIOLOGICAL

Rotarix

Intervention Type BIOLOGICAL

Paracetamol

Intervention Type DRUG

Other Intervention Names

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Rotarix Infanrix Hexa 10 valent pneumococcal conjugate vaccine

Eligibility Criteria

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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.

Minimum Eligible Age

9 Weeks

Maximum Eligible Age

16 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Brno, , Czechia

Site Status

GSK Investigational Site

Hradec Králové, , Czechia

Site Status

GSK Investigational Site

Jindřichův Hradec, , Czechia

Site Status

GSK Investigational Site

Náchod, , Czechia

Site Status

GSK Investigational Site

Ostrava, , Czechia

Site Status

GSK Investigational Site

Pardubice, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Prague, , Czechia

Site Status

GSK Investigational Site

Znojmo, , Czechia

Site Status

Countries

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Czechia

References

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Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.

Reference Type BACKGROUND

PMID: 19837254 (View on PubMed)

Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.

Reference Type BACKGROUND

PMID: 19666154 (View on PubMed)

Study Documents

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