Infections, Rotavirus
Conditions
Keywords
Pneumococcal Disease
Brief 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.
Detailed description
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
Interventions
BIOLOGICAL10 valent pneumococcal conjugate vaccine
BIOLOGICALInfanrix Hexa
BIOLOGICALRotarix
DRUGParacetamol
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Weeks to 16 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of fever > or = to 38°C (rectal temperature) | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, reactogenicity and immunogenicity pre and post-vaccination | — |
Countries
Czechia
Outcome results
None listed