Healthy infants who shall receive their first routine vaccination.
Conditions
Interventions
Trade Name: Prevenar®
Product Name: Prevenar®
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Pneumococcal polysaccharide serotype 4
Concentration unit: µg microgram(s)
Concentratio
Sponsors
Wyeth Vaccines Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 56 to 112 days of age at time of enrolment. 2. Satisfactory health as determined by a physical examination, medical history and subject’s development. 3. Subject and parents(s)/legal guardian(s) are available for the entire study period. 4. Subject’s parent(s) or legal guardian(s) have adequate literacy to understand and undertake the required study related procedures and have agreed to participate. 5. Subject’s parent(s) or legal guardian(s) have provided written informed consent after the study has been adequately and fully explained. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prematurely born subjects (infants born at <37 weeks gestation and/or birth weight <2,500 g). 2. Subjects who are not well developed according to age or are underweight in the opinion of the investigator. 3. Body weight <4,000 g at time of enrolment. 4. Known or suspected disease of the immune system or receiving immunosuppressive therapy, including systemic corticosteroids. 5. Receipt of blood products within 12 weeks prior to study entry. 6. Bleeding diathesis or condition associated with prolonged bleeding time. 7. Significant evolving neurological disorder. 8. Seizure disorders or a prior history of febrile seizures. 9. Major known congenital malformation or serious chronic disorder or genetically determined disease. 10. Any previous anaphylactic reaction or serious vaccine-associated adverse reactions. 11. Known or suspected hypersensitivity to any vaccine or vaccine component. 12. Any medical condition that would in the opinion of the investigator interfere with the evaluation of the study objectives. 13. Vaccination with any licensed or investigational vaccine (other than study vaccines allowed by this protocol): a. before enrolment (visit 1) up to visit 4. b. two (2) weeks before booster vaccination (visit 5) up to visit 6. 14. Intention to immunize with any investigational agent other than those specified in this protocol. 15. Other indications for prophylactic antipyretic treatment. 16. Subject has any contraindication to immunization with DTPa-HBV-IPV+Hib (Infanrix hexa®), or 7vPnC (Prevenar®). 17. Subject has any contraindication to treatment with paracetamol (e.g. known sensitivity to paracetamol or other components of the suppositories, functional impairment of the liver or kidney, Gilbert Syndrome, or current treatment with medication that interferes with paracetamol as described in the paracetamol SPC). 18. Participation in another investigational study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the percent reduction in the rate of febrile reactions when prophylactic antipyretic treatment is administered relative to no prophylactic antipyretic treatment after vaccination with a 7-valent pneumococcal conjugate vaccine (7vPnC, Prevenar®) and routine DTPa-HBV-IPV+Hib (Infanrix hexa®) vaccination at 2, 3, 4 (primary series) and 11-14 (booster dose) months of age.;Secondary Objective: To determine additional safety and tolerability of a single injection of 7vPnC (Prevenar®) and DTPa-HBV-IPV+Hib (Infanrix hexa®) when concomitantly administered, with or without prophylactic antipyretic treatment at 2, 3, 4 and 11-14 months of age;Primary end point(s): There are two primary endpoints. The first endpoint is any fever within days 1 to 4 post-vaccination after any of the vaccine doses 1-3. The second endpoint is any fever within days 1 to 4 post-vaccination after the fourth dose. Fever is defined as a core (rectal) temperature equal or greater than 38.0 °C. | — |
Countries
Germany
Outcome results
None listed