Last updated: 11/03/2018 09:22:18
Prophylactic antipyretic treatment in children receiving pneumococcal conjugate and standard infant vaccines
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Not applicable
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
400
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Prymula R et al. (2009) Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 374(9698):1339-1350.
Schuerman L et al. (2009) Prevention of otitis media: Now a reality? Vaccine. 27(42):5748-5754.
Silfverdal SA et al. (2016) Safety profile of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV). Expert Rev Vaccines. [Epub ahead of print]
Medical condition
Infections, Rotavirus
Product
GSK1024850A
Collaborators
Not applicable
Study date(s)
September 2006 to April 2007
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
9 - 16 weeks
Accepts healthy volunteers
Yes
- Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
- 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
Inclusion and exclusion criteria
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.
Trial location(s)
Location
GSK Investigational Site
Jindrichuv Hradec, Czech Republic, 377 01
Status
Study Complete
Showing 1 - 6 of 10 Results
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2007-10-04
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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