Study Evaluating Treatment of Fever in Children Who Have Been Vaccinated With Prevenar and Infanrix Hexa

A Randomized Controlled Open-Label Phase IV Multi Center Study to Assess the Effect of Antipyretic Prophylactic Treatment on the Rate of Febrile Reactions Following Concomitant Contralateral Administration of a 7-Valent Pneumococcal Conjugate Vaccine (Prevenar®) and DTPa-HBV-IPV+Hib Vaccine (Infanrix Hexa®) in Children at 2, 3, 4 and 11-14 Months of Age

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00294294

Enrollment

300

Registered

2006-02-20

Start date

2005-05-31

Completion date

2006-12-31

Last updated

2013-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Therapy, Combination, Fever, Chemically Induced, Infant, Vaccines, Pneumococcal

Keywords

vaccine, infant

Brief summary

The purpose of the study is to determine whether prophylactic antipyretic treatment after vaccination with Prevenar and a concomitant hexavalent DTPa combination vaccine reduces the rate of febrile reactions.

Interventions

BIOLOGICALPrevenar

BIOLOGICALInfanrix hexa

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

56 Days to 112 Days

Healthy volunteers

Yes

Inclusion criteria

* Healthy infants age 55 to 112 days * Subject's parents/legal guardians provide written informed consent

Exclusion criteria

* Prematurely born subjects \< 37 weeks gestation * Known or suspected disease of immune system * Known or suspected hypersensitivity to any vaccine or vaccine component

Design outcomes

Primary

Measure	Time frame
Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4	—

Secondary

Measure	Time frame
Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026