Infections, RotavirusPhase 3NCT00370318
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
A Phase 3 study testing 10 valent pneumococcal conjugate vaccine, Infanrix Hexa and Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 10 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 9 to 16 weeksHealthy volunteers can take part
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- 10 valent pneumococcal conjugate vaccine, Infanrix Hexa and Rotarix
- Type of treatment
- Vaccines
- How many people
- 400 participants
- Where
- 10 sitesCzechia
- Study dates
- Sep 2006to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 16 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
Who cannot join
- 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 locations and contacts
10 sites in 1 country.
10 sites in 1 country
Czechia10 sites
GSK Investigational Site
Brno, 628 00
GSK Investigational Site
Hradec Králové, 500 01
GSK Investigational Site
Jindřichův Hradec, 377 01
GSK Investigational Site
Náchod, 547 01
GSK Investigational Site
Ostrava, 728 92
GSK Investigational Site
Pardubice, 532 03
GSK Investigational Site
Prague, 150 00
GSK Investigational Site
Prague, 160 00
GSK Investigational Site
Prague, 190 00
GSK Investigational Site
Znojmo, 669 00
About this study
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
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.
Read the detailed description
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
- Conditions
- Infections, Rotavirus
- Being tested
- 10 valent pneumococcal conjugate vaccine, Infanrix Hexa, Rotarix, Paracetamol
- Keywords
- Pneumococcal Disease
- Medical subject headings
- Rotavirus Infections, Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 valent pneumococcal conjugate vaccineBiological
Infanrix HexaBiological
RotarixBiological
ParacetamolDrug
Also called Rotarix, Infanrix Hexa, 10 valent pneumococcal conjugate vaccine
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of fever > or = to 38°C (rectal temperature)
Secondary outcomes (1)
Safety, reactogenicity and immunogenicity pre and post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2006 (estimated)
- Study startSep 2006
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infections, RotavirusStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00370318
- Sponsor's protocol ID
- 107017
- Status last verified
- Mar 2017
- First submitted
- 2 Jun 2006
- Last updated
- 23 Mar 2017
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.
PubMed 19837254Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.
PubMed 19666154
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00370318
- Acronym / sponsor ID
- 107017
- Conditions
- Infections, Rotavirus
- Keywords
- Pneumococcal Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Apr 2007 (actual)
- First posted
- 31 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 9 to 16 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy children 9-16 weeks old and born after a gestation of at least 36 weeks.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 10 valent pneumococcal conjugate vaccine | Biological | – |
| Infanrix Hexa | Biological | – |
| Rotarix | Biological | – |
| ParacetamolAlso: Rotarix, Infanrix Hexa, 10 valent pneumococcal conjugate vaccine | Drug | – |
Primary outcome
Occurrence of fever > or = to 38°C (rectal temperature)
1 secondary outcome
Safety, reactogenicity and immunogenicity pre and post-vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Background: PubMed 19837254Prymula R, Siegrist CA, Chlibek R, Zemlickova H, Vackova M, Smetana J, Lommel P, Kaliskova E, Borys D, Schuerman L. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children: two open-label, randomised controlled trials. Lancet. 2009 Oct 17;374(9698):1339-50. doi: 10.1016/S0140-6736(09)61208-3.
- Background: PubMed 19666154Schuerman L, Borys D, Hoet B, Forsgren A, Prymula R. Prevention of otitis media: now a reality? Vaccine. 2009 Sep 25;27(42):5748-54. doi: 10.1016/j.vaccine.2009.07.070. Epub 2009 Aug 8.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 10 valent pneumococcal conjugate vaccine, Infanrix Hexa and Rotarix in people with Infections, Rotavirus, run by GlaxoSmithKline at 10 sites in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of fever > or = to 38°C (rectal temperature). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00370318, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.