Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

Study Overview
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Brief Summary
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A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Detailed Description
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NOTE: Detailed description has not been entered.

Official Title
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A PHASE 2, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

Conditions
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Pneumococcal Infections

Intervention / Treatment
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* Biological: Multivalent
* Biological: 13vPnC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1). Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal vaccine. Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines. Previous receipt of >1 dose of hepatitis B vaccine. Prior hepatitis B vaccine must have been administered at age <30 days. Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins

Ages Eligible for Study
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Minimum Age: 42 Days
Maximum Age: 98 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multivalent<br>Pneumococcal conjugate vaccines | Biological: Multivalent<br>* Pneumococcal conjugate vaccine<br>* Other names: Pneumococcal conjugate vaccine;|
| Active Comparator: Control<br>13vPnC | Biological: 13vPnC<br>* Pneumococcal conjugate vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (0.5 to 2.0 centimeter [cm]), moderate (greater than [>] 2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 1 | 
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 2 | 
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 3 | 
| Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4 | Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm. Redness and swelling were graded as mild (0.5 to 2.0 cm), moderate (>2.0 to 7.0 cm) and severe (>7.0 cm). Pain at injection site was graded as mild (hurt if gently touched example, whimpered, winced, protested, or withdrew), moderate (hurt if gently touched, with crying), and severe (caused limitation of limb movement). | Within 7 days after Vaccination 4 | 
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as greater than or equal to (>=) 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). | Within 7 days after Vaccination 1 | 
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). | Within 7 days after Vaccination 2 | 
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). | Within 7 days after Vaccination 3 | 
| Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4 | Systemic events included fever, decreased appetite, drowsiness, irritability and were recorded by using an electronic diary. Fever was defined as >= 38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Decreased appetite was graded as mild (decreased interest in eating), moderate (decreased oral intake) and severe (refusal to feed). Drowsiness was graded as mild (increased or prolonged sleeping bouts), moderate (slightly subdued, interfered with daily activity) and severe (disabled, not interested in usual daily activity). Irritability was graded as mild (easily consolable), moderate (required increased attention) and severe (inconsolable; crying could not be comforted). | Within 7 days after Vaccination 4 | 
| Percentage of Participants With Adverse Events (AEs) From Vaccination 1 to 1 Month After Vaccination 3 | An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship. | From Vaccination 1 to 1 month after Vaccination 3 (up to 5 months) | 
| Percentage of Participants With Adverse Events (AEs) From Vaccination 4 to 1 Month After Vaccination 4 | An AE was any untoward medical occurrence in study participant who received study vaccine without regard to possibility of causal relationship. | From Vaccination 4 to 1 month after Vaccination 4 | 
| Percentage of Participants With Serious Adverse Events (SAEs) From Vaccination 1 to 6 Months Following Vaccination 4 | An SAE is any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect. | From Vaccination 1 to 6 months after Vaccination 4 (up to 16 months) | 
| Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) From Vaccination 1 to 6 Months Following Vaccination 4 | An NDCMC is defined as a disease or medical condition, not previously identified, that is expected to be persistent or is otherwise long-lasting in its effects. | From Vaccination 1 to 6 months after Vaccination 4 (duration of 16 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Achieved Pre-specified Level of Pneumococcal IgG Concentrations Within 1 Month After Vaccination 3 | Pre-specified levels of serotypes were as follows: for serotype 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F, 33F: >=0.35 microgram per milliliter, for serotype 5: >=0.23 microgram per milliliter, for serotype 6B: >=0.10 microgram per milliliter and for serotype 19A: >=0.12 microgram per milliliter. | 1 month after Vaccination 3 | 
| Pneumococcal Serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination 3 | IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | 1 month after Vaccination 3 | 
| Pneumococcal Serotype-specific IgG GMCs at 1 Month After Vaccination 4 | IgG GMCs were determined for each of the 20 pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. | 1 Month after Vaccination 4 |