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Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01235949
First received: November 4, 2010
Last updated: April 20, 2017
Last verified: April 2017
  Purpose

The aim of the current study is to determine whether ibuprofen, given as immediate or delayed prophylactic antipyretic treatment in a standardized manner, significantly impacts the immune response in children receiving primary vaccination with GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate vaccine, co-administered with DTPa-combined vaccines, at 3, 4 and 5 months of age.

In addition, this study will further evaluate the impact of prophylactic administration of paracetamol following primary vaccination with immediate or delayed administration or when given in an immediate manner at the time of the booster dose.


Condition Intervention Phase
Infections, Streptococcal Biological: GSK1024850A (SynflorixTM) Biological: Infanrix hexa Biological: Infanrix-IPV/Hib Drug: Ibuprofen Drug: Paracetamol Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Immediate or Delayed Prophylactic Antipyretic Treatment on the Immunogenicity, Reactogenicity and Safety of GlaxoSmithKline Biologicals' Pneumococcal Vaccine 1024850A and the Co-administered DTPa-combined Vaccines

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Number of subjects with antibody concentrations against vaccine pneumococcal serotypes greater than or equal to (≥) the cut-off [ Time Frame: One month after primary immunization (At Month 3) ]
    Antibodies against the vaccine 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) have been assessed by 22F-inhibition enzyme-linked immunosorbent assay (ELISA). The cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.2 micrograms per milliliter (μg/mL).

  • Antibody concentrations against vaccine pneumococcal serotypes [ Time Frame: One month after primary immunization (At Month 3) ]
    Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

  • Antibody concentrations against protein D (anti-PD) [ Time Frame: One month after primary immunization (At Month 3) ]
    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units (EL.U) per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 100 EL.U/mL.


Secondary Outcome Measures:
  • Antibody concentrations against cross-reactive pneumococcal serotypes 6A and 19A [ Time Frame: One month after primary immunization (At Month 3) ]
    Anti-pneumococcal serotype 6A and 19A antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 0.05 μg/mL.

  • Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).

  • Number of subjects with any and Grade 3 solicited local symptoms [ Time Frame: Within the 4-day (Days 0-3) period following booster vaccination ]
    Solicited local symptoms assessed were pain, redness and swelling. Any = incidence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimeters (mm).

  • Number of subjects with any, grade 3 and related solicited general symptoms [ Time Frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses ]
    Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of subjects with any, grade 3 and related solicited general symptoms [ Time Frame: Within the 4-day (Days 0-3) period following booster vaccination ]
    Solicited general symptoms included drowsiness, irritability, loss of appetite and fever [rectally, greater than or equal to (≥) 38 degrees Celsius (°C)]. Any= incidence of any symptom regardless of intensity grade or relationship to vaccination. Grade 3 drowsiness = drowsiness that interfered with normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = fever above (>) 40.0°C. Related = symptom assessed by the investigator as related to the vaccination.

  • Number of subjects with any serious adverse events (SAEs) [ Time Frame: During the entire study period (Month 0 to 10) ]
    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.

  • Number of subjects with any unsolicited adverse events (AEs) [ Time Frame: Within 31-days (Day 0-30) following each primary vaccination dose ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

  • Number of subjects with any unsolicited adverse events (AEs) [ Time Frame: Within 31-days (Day 0-30) following booster vaccination ]
    An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.

  • Antibody concentrations against vaccine pneumococcal serotypes [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Anti- pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F antibody concentrations have been assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was an antibody concentration greater than or equal to (≥) 0.05 μg/mL.

  • Opsonophagocytic activity (OPA) titers against vaccine pneumococcal serotypes [ Time Frame: One month after primary immunization (Month 3) ]
    OPA titers against pneumococcal serotypes 1, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was an antibody titer ≥ 8.

  • Opsonophagocytic activity (OPA) titers against vaccine pneumococcal serotypes [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    OPA titers against pneumococcal serotypes (Opsono-1, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F) were presented as geometric mean titers (GMTs). The seropositivity cut-off for the assay was ≥ 8. When the number of subjects in a group for a specific category equals (=) 1, the lower limit and upper limit of the confidence interval that can't be calculated, are filled in with the GMT value (due to system constraint). Placeholder value "99999.9" has been entered when value to be entered in the system was greater than (>) 1.0 E10.

  • Antibody concentrations against protein D (anti-PD) [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in ELISA units per milliliter (EL.U//mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 100 EL.U/mL.

  • Antibody concentrations against diphtheria (D) and tetanus (T) toxoids [ Time Frame: One month after primary immunization (Month 3) ]
    Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

  • Antibody concentrations against diphteria (D) and tetanus (T) toxoids [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in IU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.1 IU/mL.

  • Antibody concentrations against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA) and pertactin (anti-PRN) [ Time Frame: One month after primary immunization (Month 3) ]
    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.

  • Antibody concentrations against pertussis toxoid (anti-PT), filamentous haemagglutinin (anti-FHA) and pertactin (anti-PRN) [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was an antibody concentration ≥ 5 EL.U/mL.

  • Antibody concentrations against hepatitis B surface antigen (HBs) [ Time Frame: One month after primary immunization (Month 3) ]
    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

  • Antibody concentrations against hepatitis B surface antigen [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in mIU/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 10 mIU/mL.

  • Antibody concentrations against polyribosyl-ribitol-phosphate (PRP) [ Time Frame: One month after primary immunization (Month 3) ]
    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

  • Antibody concentrations against polyribosyl-ribitol-phosphate (PRP) [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Antibody concentrations assessed were presented as geometric mean concentrations (GMCs) and expressed in µg/mL. The seroprotection cut-off for the assay was an antibody concentration ≥ 0.15 µg/mL.

  • Antibody titers against poliovirus type 1, 2 and 3 [ Time Frame: One month after primary immunization (Month 3) ]
    Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.

  • Antibody titers against poliovirus type 1, 2 and 3 [ Time Frame: Prior to (Month 9) and one month after booster vaccination (Month 10) ]
    Antibody titers assessed were presented as geometric mean titers (GMTs). The seroprotection cut-off for the assay was a titer ≥ the value of 8.


Enrollment: 850
Study Start Date: November 12, 2010
Study Completion Date: December 8, 2012
Primary Completion Date: March 28, 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group IIBU
Immediate ibuprofen group: subjects receiving immediate ibuprofen treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Active Comparator: Group DIBU
Delayed ibuprofen group: subjects receiving delayed ibuprofen treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Active Comparator: Group NIBU
No ibuprofen group: subjects receiving no prophylactic ibuprofen treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IPARA
Immediate paracetamol group: subjects receiving immediate paracetamol treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby
Experimental: Group DPARA
Delayed paracetamol group: subjects receiving delayed paracetamol treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby
Active Comparator: Group NPARA
No paracetamol group: subjects receiving no prophylactic paracetamol treatment after each primary vaccine dose
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IIBU-IIBU
1/3 of the subjects from the primary IIBU group receiving immediate ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group IIBU-DIBU
1/3 of the subjects from the primary IIBU group receiving delayed ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IIBU-NIBU
1/3 of the subjects from the primary IIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group DIBU-IIBU
1/3 of the subjects from the primary DIBU group receiving immediate ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group DIBU-DIBU
1/3 of the subjects from the primary DIBU group receiving delayed ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group DIBU-NIBU
1/3 of the subjects from the primary DIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group NIBU-IIBU
1/3 of the subjects from the primary NIBU group receiving immediate ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Experimental: Group NIBU-DIBU
1/3 of the subjects from the primary NIBU group receiving delayed ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Ibuprofen
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Nurofen for Children
Active Comparator: Group NIBU-NIBU
1/3 of the subjects from the primary NIBU group receiving no prophylactic ibuprofen treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group IPARA-NPARA
subjects from the primary IPARA group receiving no paracetamol treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Experimental: Group DPARA-IPARA
subjects from the primary DPARA group receiving immediate paracetamol treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby
Experimental: Group NPARA-IPARA
subjects from the primary NPARA group receiving immediate paracetamol treatment after booster vaccination
Biological: GSK1024850A (SynflorixTM)
Intramuscular injection, 4 doses
Biological: Infanrix hexa
Intramuscular injection, 3 doses
Biological: Infanrix-IPV/Hib
Intramuscular injection, 1 dose
Drug: Paracetamol
Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
Other Name: Panadol Baby

  Eligibility

Ages Eligible for Study:   12 Weeks to 16 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • A male or female between, and including, 12 and 16 weeks (84-118 days) of age at the time of the first vaccination.
  • Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccines/products within 30 days preceding the first dose of study vaccine/product, or planned use during the study period.
  • 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 or therapeutic antipyretic treatment during the study period.
  • Treatment with antipyretics in the 24 hours before study vaccination or planned administration of antipyretics in the 24 hours after study vaccination.
  • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before each dose of study vaccine and ending 30 days after with the exception of locally recommended (pandemic) influenza vaccines, and those should be documented in the eCRF.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b and/or Streptococcus pneumoniae with the exception of the vaccines where the first dose may be given within the first two weeks of life according to the national recommendations.
  • History of intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b disease.
  • History of any allergic disease or reaction likely to be exacerbated by any component of the vaccines or prophylactic antipyretic treatment, i.e. ibuprofen or paracetamol, as specified in the protocol.
  • History of any seizures or progressive neurological disease.
  • Acute disease and/or fever at the time of enrolment. The study entry should be delayed until the illness has improved.
  • 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 since birth or planned administration during entire study period.
  • Any contraindication to treatment with ibuprofen as described in the ibuprofen summary of product characteristics (SPC).
  • Any contraindication to treatment with paracetamol as described in the paracetamol SPC.
  • Body weight < 5 kg at the time of enrolment.
  • Child in care.
  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: NCT01235949

Locations
Romania
GSK Investigational Site
Bacau, Romania, 600316
GSK Investigational Site
Braila, Romania, 810289
GSK Investigational Site
Braila, Romania, 810346
GSK Investigational Site
Brasov, Romania, 500063
GSK Investigational Site
Brasov, Romania, 500260
GSK Investigational Site
Brasov, Romania, 500366
GSK Investigational Site
Bucharest, Romania, 051821
GSK Investigational Site
Bucharest, Romania, 077190
GSK Investigational Site
Bucuresti, Romania, 030442
GSK Investigational Site
Bucuresti, Romania, 050734
GSK Investigational Site
Calarasi, Romania, 910160
GSK Investigational Site
Cluj-Napoca, Romania, 400217
GSK Investigational Site
Constanta, Romania, 900709
GSK Investigational Site
Constanta, Romania, 900721
GSK Investigational Site
Galati, Romania, 800099
GSK Investigational Site
Galati, Romania, 800179
GSK Investigational Site
Galati, Romania, 800235
GSK Investigational Site
Galati, Romania, 800322
GSK Investigational Site
Galati, Romania, 800394
GSK Investigational Site
Iasi, Romania, 700115
GSK Investigational Site
Pantelimon, Romania, 77145
GSK Investigational Site
Sibiu, Romania, 550166
GSK Investigational Site
Timisoara, Romania, 300593
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 112921
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 112921
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: 112921
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: 112921
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 112921
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 112921
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01235949     History of Changes
Other Study ID Numbers: 112921
Study First Received: November 4, 2010
Last Updated: April 20, 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Pneumococcal vaccine
Immunogenicity
Safety
Fever
Primary vaccination
Booster vaccination
Pneumococcal disease
Prophylactic antipyretic

Additional relevant MeSH terms:
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Ibuprofen
Acetaminophen
Antipyretics
Immunologic Factors
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2017