A Phase 4 Study To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
A Phase 4, Randomized, Open-label Trial To Describe The Safety, Tolerability, And Immunogenicity Of 13- Valent Pneumococcal Conjugate Vaccine Formulated In Multidose Vials When Given With Routine Pediatric Vaccines In Healthy Infants In India
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
301
13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
B. J. Medical College & Civil Hospital
Ahmedabad, Gujarat, India
Manipal Hospital
Bengaluru, Karnataka, India
KEM Hospital Research Centre
Pune, Maharashtra, India
Bharati Vidyapeeth University Medical College
Pune, Maharashtra, India
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 1
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 centimeters \[cm\]), moderate (2.5 to 7.0 cm) and, severe (greater than \[\>\] 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 1
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 1
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability,were recorded daily using an electronic diary. Fever graded as:1)less than (\<)38.0 degrees Celsius \[C\], 2)greater than or equal to(\>=)38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as:mild(increased or prolonged sleeping bouts), moderate(slightly subdued; interfering with daily activity), and severe(disabling; not interested in usual daily activity). Irritability graded as: mild(easily consolable), moderate(required increased attention), and severe(inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here,"Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 1
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 2
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
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Sri Ramachandra Hospital
Chennai, Tamil Nadu, India
Kanchi Kamakoti Childs Trust Hospital
Chennai, Tamil Nadu, India
Sir Ganga Ram Hospital
New Delhi, India
Time frame: Within 7 days after Vaccination 2
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 2
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 2
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 3
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 3
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 3
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 3
Percentage of Participants With Local Reactions Within 7 Days After Vaccination 4
Local reactions were recorded daily using an electronic diary. Local reactions included redness, swelling and pain at injection site. Redness and swelling were graded as mild (0.5 to 2.5 cm), moderate (2.5 to 7.0 cm) and, severe (\> 7 cm). Pain at injection site was graded as mild (hurt if gently touched (example, whimpers, winces, protests, or withdraws), moderate (hurt if gently touched \[with crying\]), and severe (caused limitation of limb movement). Participants may be represented in more than 1 row. Here, "Any" for redness, swelling and pain at injection site represents any grade of these local reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 4
Percentage of Participants With Systemic Events Within 7 Days After Vaccination 4
Systemic events included fever, decreased appetite, drowsiness(increased sleep) and irritability, were recorded daily using an electronic diary. Fever graded as:1) \< 38.0 degrees C, 2) \>= 38.0 degree C to 38.4 degree C, 3)38.5 degree C to 38.9 degree C, 4) 39.0 degree C to 40.0 degree C, 5) \>40.0 degree C. Decreased appetite graded as: mild(decreased interest in eating), moderate(decreased oral intake), and severe(refusal to feed). Drowsiness graded as: mild (increased or prolonged sleeping bouts), moderate (slightly subdued; interfering with daily activity), and severe (disabling; not interested in usual daily activity). Irritability graded as: mild (easily consolable), moderate (required increased attention), and severe (inconsolable; crying could not be comforted). Participants may be represented in \>1 row. Here, "Any" for decreased appetite, drowsiness, irritability represents any grade of these systemic reactions among mild, moderate or severe.
Time frame: Within 7 days after Vaccination 4
Percentage of Participants With Adverse Events (AEs) After Vaccination 1 up to 1 Month After Vaccination 3
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Time frame: From Vaccination 1 up to 1 Month after Vaccination 3 (for a maximum study duration of 3 months)
Percentage of Participants With Adverse Events (AEs) From Vaccination 4 up to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship.
Time frame: From Vaccination 4 up to 1 month after Vaccination 4 (for a maximum study duration of 1 month)
Percentage of Participants With Serious Adverse Events (SAEs) After Vaccination 1 up to 1 Month After Vaccination 4
An AE was any untoward medical occurrence in a participant who received study vaccine without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: From Vaccination 1 up to 1 month after Vaccination 4 (for a maximum study duration of 11.5 months)
Number of Participants With New Diagnosed Chronic Medical Condition (NDCMC) From 1 Month After Vaccination 3 up to Vaccination 4
A newly diagnosed chronic medical condition was defined as a disease or medical condition, not previously identified, that was expected to be persistent or otherwise long-lasting in its effects.
Time frame: From 1 month after Vaccination 3 up to Vaccination 4 (for a maximum study duration of 7.5 months)
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Percentage of participants achieving predefined antibody threshold: \>=0.35 microgram per milliliter (mcg/mL) for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F; threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95 percent (%) confidence interval (CI) are reported.
Time frame: 1 month after Vaccination 3
Percentage of Participants With Immunoglobulin G (IgG) Concentrations Greater Than or Equal to (>=) Pre-defined Thresholds for Each of the Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL for the 10 pneumococcal serotypes 1, 3, 4, 6A, 7F, 9V, 14, 18C, 19F and 23F, threshold \>= 0.23 mcg/mL for serotype 5, threshold \>= 0.10 mcg/mL for serotype 6B, threshold \>= 0.12 mcg/mL for serotype 19A, along with the corresponding 95% CI are reported.
Time frame: 1 month after Vaccination 4
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Time frame: 1 month after Vaccination 3
Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Antibody (IgG) GMCs for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) and corresponding 2-sided 95% CI are reported.
Time frame: 1 month after Vaccination 4
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Time frame: 1 month after Vaccination 3
Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) was measured centrally using a pneumococcal OPA assay. Initial results were measured as OPA titers, which were then logarithmically transformed for analysis; geometric means calculated and expressed as GMTs.
Time frame: 1 month after Vaccination 4
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 3
Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Time frame: 1 month after Vaccination 3
Percentage of Participants With Opsonophagocytic Activity (OPA) Titers >= Lower Limit of Quantitation (LLOQ) for Each of Pneumococcal Serotypes Measured 1 Month After Vaccination 4
Percentage of participants achieving OPA titer \>=LLOQ along with 95% CI for the 13 pneumococcal serotypes (serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of participants was presented. LLOQ (measured in mcg/mL) for each serotype is as follows: Serotype 1=18; Serotype 3=12; Serotype 4=21; Serotype 5=29; Serotype 6A=37; Serotype 6B=43; Serotype 7F=113; Serotype 9V=141; Serotype 14=35; Serotype 18C=31; Serotype 19A=18; Serotype 19F=48; Serotype 23F=13.
Time frame: 1 month after Vaccination 4