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

Infections, Rotavirus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370318
• Other study ID #: 107017
• Status: Completed
• Phase: Phase 3
• First received: June 2, 2006
• Last updated: March 21, 2017
• Start date: September 2006
• Est. completion date: April 2007

Study information

• Verified date: March 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Weeks to 16 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infections, Rotavirus
• Rotavirus Infections

Intervention

Biological:
• 10 valent pneumococcal conjugate vaccine

• Infanrix Hexa

• Rotarix

Drug:
• Paracetamol

Locations

Country	Name	City	State
Czech Republic	GSK Investigational Site	Brno
Czech Republic	GSK Investigational Site	Hradec Kralove
Czech Republic	GSK Investigational Site	Jindrichuv Hradec
Czech Republic	GSK Investigational Site	Nachod
Czech Republic	GSK Investigational Site	Ostrava
Czech Republic	GSK Investigational Site	Pardubice
Czech Republic	GSK Investigational Site	Praha 5
Czech Republic	GSK Investigational Site	Praha 6
Czech Republic	GSK Investigational Site	Praha 9
Czech Republic	GSK Investigational Site	Znojmo

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Czech Republic, 

References & Publications (2)

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of fever > or = to 38°C (rectal temperature)
Secondary	Safety, reactogenicity and immunogenicity pre and post-vaccination

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.