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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.
2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 10 valent pneumococcal conjugate vaccine | Biological | |||
| Infanrix Hexa | Biological | |||
| Rotarix | Biological | |||
| Paracetamol | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of fever > or = to 38°C (rectal temperature) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, reactogenicity and immunogenicity pre and post-vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Brno | 628 00 | Czechia | |||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19837254 | Background | 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. | |
| 19666154 |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 107017 | Individual Participant Data Set | View IPD |
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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| Hradec Králové |
| 500 01 |
| Czechia |
| GSK Investigational Site | Jindřichův Hradec | 377 01 | Czechia |
| GSK Investigational Site | Náchod | 547 01 | Czechia |
| GSK Investigational Site | Ostrava | 728 92 | Czechia |
| GSK Investigational Site | Pardubice | 532 03 | Czechia |
| GSK Investigational Site | Prague | 150 00 | Czechia |
| GSK Investigational Site | Prague | 160 00 | Czechia |
| GSK Investigational Site | Prague | 190 00 | Czechia |
| GSK Investigational Site | Znojmo | 669 00 | Czechia |
| Schuerman 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. |
For additional information about this study please refer to the GSK Clinical Study Register |
| 107017 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107017 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107017 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107017 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 107017 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| C586648 | 10-valent pneumococcal conjugate vaccine |
| C541235 | diphtheria-tetanus-acellular pertussis-inactivated poliovirus-Haemophilus influenzae b conjugate-hepatitis B vaccine |
| C492457 | RIX4414 vaccine |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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