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Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Conjugate Vaccine GSK1024850A

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00496015
First received: July 3, 2007
Last updated: May 8, 2017
Last verified: May 2017
  Purpose

The purpose of this trial is to assess if the rate of febrile reactions following the co-administration of a booster dose of pneumococcal conjugate vaccines with standard infant vaccines is lowered when paracetamol is given prophylactically and to assess the impact of pneumococcal conjugate vaccine on pneumococcal and H. influenzae nasopharyngeal carriage compared to control group receiving meningococcal conjugate vaccine (GSK134612).

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00370318).


Condition Intervention Phase
Infections, Streptococcal Biological: Pneumococcal conjugate vaccine GSK1024850A. Biological: Infanrix hexa. Biological: Meningococcal vaccine GSK134612. Drug: Paracetamol. Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Prophylactic Antipyretic Treatment in Children Receiving Booster Dose of Pneumococcal Vaccine GSK1024850A and DTPa-HBV-IPV/Hib Vaccine (Infanrix Hexa) and Assessment of Impact of Pneumococcal Vaccination on Nasopharyngeal Carriage

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects reported with core fever (rectal temperature) greater than or equal to (≥) the cut-off [ Time Frame: Within 4 days (Day 0-3) after primary vaccine dose. ]
    The cut-off for core fever was 38.0 degrees Celsius (ºC).


Secondary Outcome Measures:
  • Number of subjects reported with core fever (rectal temperature) greater than (>) the cut-off [ Time Frame: Within 4 days (Day 0-3) after primary vaccination dose ]
    The cut-off value for core fever (rectal temperature) was 39.0ºC.

  • Number of subjects reported with any and Grade 3 solicited local symptoms. [ Time Frame: Within 4 days after primary vaccination. ]
    Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling > 30 millimeters from injection site.

  • Number of subjects reported with any and Grade 3 solicited general symptoms [ Time Frame: Within 4 days after the administration of the vaccine dose. ]
    Solicited general symptoms assessed were drowsiness, fever (rectal temperature ≥ 38.5°C), irritability and loss of appetite. Any was defined as any occurrence of the specified symptom regardless of intensity and relation to vaccination. Grade 3 drowsiness was defined as drowsiness that prevented normal activity. Grade 3 fever was defined as rectal temperature >40.0°C. Grade 3 irritability was defined as crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite was defined as not eating at all.

  • Number of subjects reported with unsolicited adverse events (AEs) [ Time Frame: Within 31 days (Day 0-30) after primary vaccine dose. ]

    The outcome measure was not reporting statistics for all the arms in the baseline period. Results were tabulated on baseline groups except for the Synforix PRE and Synforix POST groups, for which results were presented for the Pooled Synforix PRE and POST Group.

    An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.


  • Number of subjects reported with serious adverse events (SAEs) [ Time Frame: Throughout the entire study period (Month 0-Month 12) ]
    Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

  • Number of subjects reported with AEs resulting in rash, new onset of chronic illness (NOCI), emergency room (ER) visits and non-routine physician office visits. [ Time Frame: Up to 6 months after vaccination with Mencevax™ ]
    Results were tabulated only on Mencevax + Infanrix Hexa Group, according to the outcome measure specification of the protocol.

  • Number of subjects with antibody concentrations against certain pneumococcal serotypes ≥ the cut off [ Time Frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination ]

    Certain pneumococcal serotypes includes pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F). Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

    The seroprotection cut-off for the assay was ≥ 0.2 microgram per milliliter (μg/mL).


  • Antibody concentrations against certain pneumococcal serotypes ≥ the cut off. [ Time Frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination ]

    Certain pneumococcal serotypes included pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F).

    Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

    Seropositivity cut-off for the assay was ≥ 0.05 microgram per milliliter (μg/mL).


  • Opsonophagocytic activity (OPA) titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F [ Time Frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination ]
    OPA titers against pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Opsono-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

  • Concentrations of antibodies against protein D (Anti-PD) [ Time Frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination ]
    The seropositivity cut-off for the assay was ≥ 100 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per milliliter (EL.U/mL).

  • Antibody concentrations against pneumococcal serotypes 6A and 19A (anti-6A and 19A) [ Time Frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination ]
    Anti-6A and 19A antibody concentrations were measured by 22F-inhibition Enzyme-Linked ImmunoSorbent Assay (ELISA).

  • Opsonophagocytic activity (OPA) titers against pneumococcal cross-reactive serotypes 6A and 19A [ Time Frame: Prior to booster vaccination (PRE), 1 month (M1) and 12 months (M12) post-booster vaccination ]
    OPA titers against pneumococcal serotypes 6A and 19A (Opsono-6A and 19A) were calculated, expressed as geometric mean titers (GMTs) and tabulated. The seropositivity cut-off for the assay was ≥ 8.

  • Number of subjects with serum bactericidal antibodies, using baby rabbit complement for assay (rSBA) titres ≥ the cut-off values [ Time Frame: Prior to vaccination (PRE), 1 month (M1) and 12 months (M12) post-vaccination ]

    The cut-off values assessed were 1:8 and 1:128 for meningococcal polysaccharides A , C, W-135 and Y serum bactericidal antibodies, using baby rabbit complement for assay (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY).

    Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).


  • rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY titers in the Mencevax + Infanrix Hexa Group [ Time Frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination. ]
    Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  • Number of subjects with anti-polysaccharide N (anti-PS) concentrations ≥ the cut-off values [ Time Frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post-vaccination ]
    Anti-PS assessed were anti-PS meningitidis serogroup A (anti-PSA), C (anti-PSC), W (anti-PSW-135) and Y (anti-PSY). The cut-offs for anti-PS concentrations were 0.3 μg/mL and 2.0 μg/mL, tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  • Geometric mean antibody concentration (GMCs) for anti-polysaccharide N (anti-PS) antibody concentrations [ Time Frame: Prior to vaccination(PRE), 1 month (M1) and 12 months (M12) post- vaccination. ]
    Anti-PS assessed were Anti-PSA, anti-PSC, anti-PSW-135 and anti-PSY. Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group).

  • Anti-tetanus toxoids (anti-T) antibody concentrations in the Mencevax + Infanrix Hexa Group [ Time Frame: Prior to vaccination (Pre) ]
    The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

  • Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations in the Mencevax + Infanrix Hexa Group [ Time Frame: Prior to vaccination (Pre) ]
    The seroprotection cut-off for the assay was ≥ 10 milli international units per milliliter (mIU/mL). Results were only tabulated for subjects who received a vaccine including the respective antigens (Mencevax + Infanrix Hexa Group). Dummy lower limit (LL) (0.0) and upper limit UL (99999.9) were entered when number of subjects analysed = 1.

  • Concentrations of antibodies against diphtheria and tetanus toxoids (anti-D and T). [ Time Frame: 1 month post-vaccination (M1) ]
    The seroprotection cut-off for the assay was ≥ 0.1 international units per milliliter (IU/mL).

  • Anti-pertussis toxoid (anti-PT), anti-filamentous haemagglutinin (anti-FHA) and anti-pertactin (anti-PRN) antibody concentrations [ Time Frame: 1 month post-vaccination (M1) ]
    The seropositivity cut-off for the assay was ≥ 5 Enzyme-Linked ImmunoSorbent Assay (ELISA) units per millimiter (EL.U/mL).

  • Anti-hepatitis B surface antigen (anti-HBs) antibody concentrations [ Time Frame: 1 month post-vaccination (M1) ]
    The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

  • Anti-polyribosyl-ribitol phosphate (anti-PRP) antibody concentrations [ Time Frame: 1 month post-vaccination (M1) ]
    The seroprotection cut-off for the assay was ≥ 0.15 μg/mL.

  • Anti-poliovirus (Anti-Polio) types 1, 2 and 3 titers [ Time Frame: 1 month post-vaccination (M1) ]
    The seroprotection cut-off for the assay was ≥ 8.

  • Anti-hepatitis B surface antigen (Anti-HBs) antibody concentrations [ Time Frame: 12 month post-vaccination (M12) ]
    The seroprotection cut-off for the assay was ≥ 10 mIU/mL.

  • Anti-poliovirus (Anti-Polio) type 1, 2 and 3 titers [ Time Frame: 12 month post-vaccination (M12) ]
    The seroprotection cut-off for the assay was ≥ 8.

  • Number of nasopharyngeal swabs with S.pneumoniae (vaccine serotypes) [ Time Frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

  • Number of nasopharyngeal swabs with S.pneumoniae (cross-reactive serotypes) [ Time Frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Pooled Synflorix Group and on Mencevax + Infanrix Hexa Group.

  • Number of nasopharyngeal swabs with S.pneumoniae (non-vaccine and non-cross-reactive serotypes) [ Time Frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  • Number of nasopharyngeal swabs with H. influenzae [ Time Frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  • Number of nasopharyngeal swabs with S. pneumoniae and H. influenzae [ Time Frame: Prior to vaccination(Pre), 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  • Number of subjects with new acquisition associated to S. pneumoniae detected in nasopharyngeal swabs [ Time Frame: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.

  • Number of subjects with new acquisition associated to H. influentzae detected in nasopharyngeal swabs. [ Time Frame: 1 month post-vaccination (M1), 3 months post-vaccination (M3), 7 months post-vaccination (M7), 12 months post-vaccination (M12) and across all time points (Overall) ]
    Results were tabulated on Mencevax + Infanrix Hexa Group and on Pooled Synflorix Group.


Enrollment: 750
Actual Study Start Date: July 2, 2007
Study Completion Date: February 17, 2009
Primary Completion Date: March 25, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Synflorix I Group
Subjects were vaccinated with 3 primary vaccination doses of Synflorix™ vaccine with prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa along with prophylactic antipyretic treatment.
Biological: Pneumococcal conjugate vaccine GSK1024850A.
1 intramuscular injection.
Biological: Infanrix hexa.
1 intramuscular injection.
Other Name: DTPa-HBV-IPV/Hib
Drug: Paracetamol.
Body weight of < 7 kg: none; Body weight of ≥ 7 kg to < 9 kg : 3 suppositories of 125 mg to be administered at 8h intervals after vaccination. Body weight of ≥ 9 kg: 4 suppositories of 125 mg to be administered at 6h intervals after vaccination.
Experimental: Synflorix II Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment
Biological: Pneumococcal conjugate vaccine GSK1024850A.
1 intramuscular injection.
Biological: Infanrix hexa.
1 intramuscular injection.
Other Name: DTPa-HBV-IPV/Hib
Experimental: Synflorix PRE Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (before the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
Biological: Pneumococcal conjugate vaccine GSK1024850A.
1 intramuscular injection.
Biological: Infanrix hexa.
1 intramuscular injection.
Other Name: DTPa-HBV-IPV/Hib
Experimental: Synflorix POST Group
Subjects were vaccinated with 3 primary vaccination doses of Synforix™ vaccine without prophylactic administration of paracetamol in study 10PN-PD-DIT-010 (107017), and received in this study (after the implementation of the protocol amendment) at 12-15 months of age a booster dose of Synforix™ vaccine, co-administered with Infanrix™ hexa without prophylactic antipyretic treatment.
Biological: Pneumococcal conjugate vaccine GSK1024850A.
1 intramuscular injection.
Biological: Infanrix hexa.
1 intramuscular injection.
Other Name: DTPa-HBV-IPV/Hib
Active Comparator: Mencevax + Infanrix Hexa Group
Age-matched pneumococcal vaccine unprimed group receiving a single dose of Mencevax™ vaccine co-administered with Infanrix™ hexa vaccine.
Biological: Infanrix hexa.
1 intramuscular injection.
Other Name: DTPa-HBV-IPV/Hib
Biological: Meningococcal vaccine GSK134612.
1 intramuscular injection.
Other Name: Mencevax™

Detailed Description:
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
  Eligibility

Ages Eligible for Study:   12 Months to 15 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 12-15 months of age at the time of the vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Subjects in the unprimed group

• A male or female who previously participated in study 107017 and received 3 doses of pneumococcal conjugate vaccine GSK1024850A.

Exclusion Criteria:

For all subjects:

  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product
  • Indication, other than specified in the protocol, for prophylactic antipyretic treatment.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the dose of study vaccines, or planned use during the entire study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the dose of study vaccines.
  • Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the dose of study vaccines and up to one month after the dose of study vaccines.
  • History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease.
  • Acute disease at the time of enrolment.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • A family history of congenital or hereditary immunodeficiency.
  • Major congenital defects or serious chronic illness.
  • Administration of immunoglobulins and/or any blood products within three months preceding administration of the dose of study vaccines or planned administration during the study period.
  • Subjects of which both parents have a history of atopia.
  • Subject has received systemic antibiotic therapy for acute illness within 24 hours prior to the vaccination.
  • Subject is likely to receive antipyretic treatment as a result of a concomitant illness or has been treated with paracetamol within the past 24 hours.

DTPa-HBV-IPV/Hib vaccine:

  • Known hypersensitivity after previous administration of diphtheria, tetanus, pertussis, polio, hepatitis B and Hib vaccines or to any component of the vaccines.
  • Encephalopathy.
  • As with other vaccines, administration of DTPa-HBV-IPV/Hib should be postponed in subjects suffering from acute mild, moderate or severe illness.

For subjects in the AP-AP, AP-NAP and NAP groups:

• Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenzae type b vaccines other than allowed and used in study 107017.

For subjects in the AP-AP group:

• Subject with any contraindication to treatment with paracetamol.

For subjects in the unprimed group:

  • Previous vaccination with meningococcal polysaccharide vaccine of serogroup A, C, W-135 and/or Y.
  • Previous vaccination with meningococcal polysaccharide conjugate vaccine of serogroups A, C, W-135 and/or Y.
  • Planned administration of a hepatitis B vaccine not foreseen by the study protocol during the period starting one month after the dose of study vaccines and up to study end.
  • Previous vaccination with tetanus toxoid containing vaccines including T, DTP, DT, DTP-IPV, DTP-HBV-IPV and Hib-TT vaccines six months prior to study entry.
  • History of meningococcal disease due to serogroup A, C, W, or Y.
  • Administration of any pneumococcal vaccine since birth.
  • Full vaccination history since birth not available.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496015

Locations
Czechia
GSK Investigational Site
Brno, Czechia, 628 00
GSK Investigational Site
Hradec Kralove, Czechia, 500 01
GSK Investigational Site
Jindrichuv Hradec, Czechia, 377 01
GSK Investigational Site
Nachod, Czechia, 547 01
GSK Investigational Site
Ostrava, Czechia, 728 92
GSK Investigational Site
Pardubice, Czechia, 532 03
GSK Investigational Site
Praha 5, Czechia, 150 00
GSK Investigational Site
Praha 6, Czechia, 1600
GSK Investigational Site
Praha 9, Czechia, 190 00
GSK Investigational Site
Znojmo, Czechia, 669 00
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Prymula R et al. Does prophylactic paracetamol influence the effect of 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine (PHiD-CV) on pneumococcal nasopharyngeal carriage? Abstract presented at the 7th International Symposium on Pneumococci and Pneumococcal Diseases (ISPPD). Tel Aviv, Israel, 14-18 March 2010.
Prymula R et al. Effects on serotype 6A and 6B nasopharyngeal carriage following immunization with 10-valent pneumococcal non-typeable Haemophilus influenzae protein-D conjugate vaccine. Abstract presented at the 28th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Nice, France, 4-8 May 2010.
Prymula R et al. Limited clinical benefit but reduced antibody responses to paediatric vaccines following prophylactic paracetamol administration. Abstract presented at the 4th Europaediatrics, Moscow, Russia, 03-06 July 2009.
Prymula R et al. The 10-valent pneumococcal vaccine conjugated to protein-D (PHiD-CV) reduces nasopharyngeal carriage of Streptococcus pneumoniae (SP) vaccine serotypes in Czech children. Abstract presented at the 6th World Congress of the World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 19-22 November 2009.

Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 107137
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00496015     History of Changes
Other Study ID Numbers: 107137
Study First Received: July 3, 2007
Last Updated: May 8, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
Streptococcus Pneumoniae Vaccines
Meningococcal disease
Carriage
Prophylactic antipyretic
Safety
Pneumococcal vaccine
Fever
Pneumococcal disease
Immunogenicity
Meningococcal vaccine
Booster vaccination

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Acetaminophen
Antipyretics
Immunologic Factors
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on June 26, 2017