CClinicalTrials.gg
CompletedNCT00294294Updated Feb 21, 2013

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

A Phase 4 interventional study of Prevenar and Infanrix hexa in Vaccines, Pneumococcal, Infant and Fever, Chemically Induced, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer. Completed. Open to participants aged 56 Days to 112 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-21.

Sponsored by Wyeth is now a wholly owned subsidiary of Pfizer · Phase 4, Interventional, and Prevention

Phase
Phase 4
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
56 Days to 112 Days
Sex
All
01

Study 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.

02

Conditions studied

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

Browse trials for

Keywords

  • vaccine
  • infant
03

In context

Fever

601 studies on the registry are indexed under Fever; 101 are open to participants now.

This study's enrollment of 300 is above the median of 100 across 382 interventional studies indexed under Fever.

Browse Fever studies →

Lead sponsor

Wyeth is now a wholly owned subsidiary of Pfizer is the lead sponsor of 472 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
56 Days to 112 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants

Interventions

  • BiologicalPrevenar
  • BiologicalInfanrix hexa
06

What researchers measure

Primary outcomes

  1. Rectal temperature >= 38°C within days 1-4 post vaccination after any of the doses 1-4

Secondary outcomes

  1. Rectal temperature > 39.0°C occurring within 4 days of vaccine administration after each of the doses 1-4

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Rose MA, Juergens C, Schmoele-Thoma B, Gruber WC, Baker S, Zielen S. An open-label randomized clinical trial of prophylactic paracetamol coadministered with 7-valent pneumococcal conjugate vaccine and hexavalent diphtheria toxoid, tetanus toxoid, 3-component acellular pertussis, hepatitis B, inactivated poliovirus, and Haemophilus influenzae type b vaccine. BMC Pediatr. 2013 Jun 21;13:98. doi: 10.1186/1471-2431-13-98. PubMed 23786774 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 21, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00294294
Lead sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
First posted
Feb 20, 2006
Start date
May 2005
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Feb 21, 2013

Study contacts

Medical Monitor
study director · Wyeth is now a wholly owned subsidiary of Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion