NCT01235949 - Primary and Booster Vaccination Study With Pneumococcal Vaccine GSK1024850A and Prophylactic Antipyretic Treatment | Crick

Eligibility

Sex: ALLMin age: 12 WeeksMax age: 16 WeeksHealthy volunteers:

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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.

Outcomes

Primary Outcomes

Number of Subjects With Antibody Concentrations Against Vaccine Pneumococcal Serotypes Greater Than or Equal to (≥) the Cut-off

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).

Time frame: One month after primary immunization (At Month 3)

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

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.

Time frame: One month after primary immunization (At Month 3)

Antibody Concentrations Against Protein D (Anti-PD)

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.

Time frame: One month after primary immunization (At Month 3)

Secondary Outcomes

Antibody Concentrations Against Cross-reactive Pneumococcal Serotypes 6A and 19A

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.

Time frame: One month after primary immunization (At Month 3)

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

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).

Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

Number of Subjects With Any and Grade 3 Solicited Local Symptoms

Time frame: Within the 4-day (Days 0-3) period following booster vaccination

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

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.

Time frame: Within the 4-day (Days 0-3) post-primary vaccination period following each dose and across doses

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

Number of Subjects With Any Serious Adverse Events (SAEs)

SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity.

Time frame: During the entire study period (Month 0 to 10)

Number of Subjects With Any Unsolicited Adverse Events (AEs)

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.

Time frame: Within 31-days (Day 0-30) following each primary vaccination dose

Number of Subjects With Any Unsolicited Adverse Events (AEs)

Time frame: Within 31-days (Day 0-30) following booster vaccination

Antibody Concentrations Against Vaccine Pneumococcal Serotypes

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.