Pneumococcal Vaccines
Conditions
Keywords
Prevenar 13, 13vPnC, Antipyretic medication, Healthy subjects
Brief summary
The purposes of this study are assess the immunological response (measure the amount of antibodies, i.e. proteins that fight off germs) produced by children after they have been given the 13-valent pneumococcal vaccine (13vPnC) and INFANRIX hexa at 2, 3, 4 and 12 months of age when medications to prevent fever are given on the same day as the vaccination. Also to evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in children who receive medications to prevent fever on the day of vaccination.
Interventions
BIOLOGICAL13-valent pneumococcal conjugate vaccine
13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
BIOLOGICALINFANRIX hexa
INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
DRUGParacetamol
Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
DRUGIbuprofen
Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
56 Days to 98 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged 2 months (56 to 98 days) at time of enrollment. * Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
Exclusion criteria
* Previous vaccination with licensed or investigational pneumococcal, diphtheria, tetanus, pertussis, polio, or Hib conjugate vaccines. * A previous anaphylactic reaction to any vaccine or vaccine-related component. * Allergy or contraindication to paracetamol or ibuprofen administration. * Contraindication to vaccination with pneumococcal conjugate, diphtheria, tetanus, pertussis, polio, Hib, or HBV vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 month after the infant series | Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively. |
| Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 month after the infant series | Percentage of participants achieving serotype-specific pneumococcal OPA titer \>= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13. |
| Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 month after the infant series | Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs). |
| Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. |
| Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. |
| Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | 1 month after the infant series | Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody. |
| Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | 1 month after the toddler dose | Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies. |
| Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | 1 month after the toddler dose | Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies. |
| Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 month after the infant series | Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. |
| Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | 1 month after the toddler dose | Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies. |
| Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | 1 month after the infant series | Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate \[PRP\] \>=0.15 mcg/mL; Hib PRP \>=1 mcg/mL; Pertussis PT \>=14.6 EU/mL, FHA \>=16.1 EU/mL, PRN \>=24.0 EU/mL; Tetanus \>=0.1 IU/mL; Diphtheria \>=0.1 IU/mL; HBV \>=10 mIU/mL; Poliomyelitis Type 1, 2, 3 \>=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group. |
| Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | 1 month after the toddler dose | Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate \[PRP\] \>=0.15 mcg/mL; Hib PRP \>=1 mcg/mL; Pertussis PT \>=14.8 EU/mL, FHA \>=46.5 EU/mL, PRN \>=43.5 EU/mL; Tetanus \>=0.1 IU/mL; Diphtheria \>=0.1 IU/mL; HBV \>=10 mIU/mL; Poliomyelitis Type 1, 2, 3 \>=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group. |
| Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Within 4 days after infant series Dose 1 | Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree Celsius (degree C), greater than (\>) 39 but \<=40 degree C and \>40 degree C. |
| Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Within 4 days after infant series Dose 2 | Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C. |
| Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Within 4 days after infant series Dose 3 | Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C. Report of fever \>40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error. |
| Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Within 4 days after toddler dose | Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C. |
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | Baseline up to 1 Month (28 to 42 days) after infant series | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment). |
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment). |
| Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | Toddler dose up to 1 Month (28 to 42 days) after toddler dose | An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment). |
| Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose | 1 month after the toddler dose | Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody. |
Countries
Poland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (greater than or equal to \[\>=\]56 to less than or equal to \[\<=\]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol. | 173 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen. | 176 |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol. | 172 |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen. | 177 |
| 13vPnC + INFANRIX Hexa Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer's instructions at 2 months (\>=56 to \<=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age. | 210 |
| Total | 908 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| After Infant Series | Lost to Follow-up | 0 | 0 | 1 | 0 | 0 |
| After Infant Series | Withdrawal by Parent | 0 | 1 | 1 | 0 | 1 |
| Infant Series | Adverse Event | 0 | 0 | 0 | 1 | 0 |
| Infant Series | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Infant Series | Protocol Violation | 0 | 1 | 0 | 0 | 0 |
| Infant Series | Withdrawal by Parent | 4 | 1 | 0 | 0 | 0 |
| Toddler Dose | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 |
| Toddler Dose | Withdrawal by Parent | 0 | 1 | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | 13vPnC + INFANRIX Hexa | 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Total |
|---|---|---|---|---|---|---|
| Age, Continuous | 65.6 days STANDARD_DEVIATION 9.4 | 65.1 days STANDARD_DEVIATION 9.5 | 66.5 days STANDARD_DEVIATION 10.1 | 65.6 days STANDARD_DEVIATION 9.7 | 66.4 days STANDARD_DEVIATION 10.3 | 65.8 days STANDARD_DEVIATION 9.8 |
| Sex: Female, Male Female | 98 Participants | 87 Participants | 89 Participants | 75 Participants | 79 Participants | 428 Participants |
| Sex: Female, Male Male | 112 Participants | 86 Participants | 87 Participants | 97 Participants | 98 Participants | 480 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 57 / 173 | 71 / 176 | 67 / 172 | 72 / 177 | 80 / 210 | 3 / 170 | 6 / 174 | 3 / 172 | 4 / 176 | 8 / 210 | 47 / 169 | 57 / 173 | 52 / 170 | 76 / 175 | 50 / 209 |
| serious Total, serious adverse events | 7 / 173 | 3 / 176 | 11 / 172 | 8 / 177 | 10 / 210 | 6 / 170 | 14 / 174 | 10 / 172 | 11 / 176 | 9 / 210 | 3 / 169 | 2 / 173 | 1 / 170 | 1 / 175 | 1 / 209 |
Outcome results
Primary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series
Antibody geometric least squares (LS) mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95 percent (%) confidence interval (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
Time frame: 1 month after the infant series
Population: Modified intent-to-treat (mITT) infant immunogenicity set: all eligible participants who had \>=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization,may have had received additional anti-pyretic medication,had blood drawn within specified time frames,had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 1.12 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 0.97 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 4.45 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 1.94 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 2.70 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 1.13 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 0.79 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 1.47 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 1.64 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 0.68 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n= 137, 155, 148, 146, 210) | 0.85 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 0.71 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 1.78 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 1.25 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 0.91 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 1.50 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n= 137, 155, 148, 146, 210) | 1.19 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 1.99 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 2.22 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 1.45 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 3.39 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 2.30 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 4.73 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 0.98 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 1.73 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 0.83 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n= 137, 155, 148, 146, 210) | 0.73 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 1.48 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 0.56 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 1.17 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 4.75 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 1.25 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 1.59 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 1.02 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 0.57 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 0.63 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 0.85 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 1.83 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 2.53 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 5.26 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 1.22 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 2.07 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 0.90 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 0.90 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 3.14 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 2.28 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n= 137, 155, 148, 146, 210) | 1.07 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 1.75 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 0.84 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 2.04 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 1.40 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 1.29 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 3.02 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 1.54 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 2.02 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 0.88 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 5.38 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 0.81 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 1.31 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 1.25 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 1.10 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 0.81 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 23F (n= 137, 155, 148, 146, 210) | 1.04 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 1.99 microgram per milliliter (mcg/mL) |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 2.15 microgram per milliliter (mcg/mL) |
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.86, 1.42]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.085695% CI: [0.69, 0.96]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.854695% CI: [0.84, 1.16]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.001295% CI: [0.62, 0.86]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.87, 1.2]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.241295% CI: [0.64, 1.08]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.454895% CI: [0.88, 1.44]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.009395% CI: [0.53, 0.88]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.174995% CI: [0.75, 1]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.312195% CI: [0.96, 1.27]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.135195% CI: [0.78, 1.03]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.93, 1.24]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.215895% CI: [0.67, 1.03]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.327995% CI: [0.71, 1.08]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.247295% CI: [0.72, 1.09]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.79, 1.21]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.619395% CI: [0.81, 1.12]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.312195% CI: [0.96, 1.32]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.019195% CI: [0.7, 0.96]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.97, 1.33]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.241295% CI: [0.76, 1.05]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.312195% CI: [0.99, 1.35]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.013595% CI: [0.68, 0.94]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.87, 1.21]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.174995% CI: [0.66, 1]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.312195% CI: [0.93, 1.41]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.82, 1.11]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.003895% CI: [0.57, 0.86]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.84, 1.27]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.241295% CI: [0.76, 1.06]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.205395% CI: [1.02, 1.41]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.024195% CI: [0.7, 0.96]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.88, 1.22]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.073295% CI: [0.69, 0.94]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.60995% CI: [0.82, 1.1]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: <0.000195% CI: [0.56, 0.76]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.782895% CI: [0.82, 1.16]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.205395% CI: [1.02, 1.43]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.009395% CI: [0.65, 0.92]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.93, 1.31]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.241295% CI: [0.73, 1.07]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.312195% CI: [0.95, 1.37]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.013595% CI: [0.64, 0.93]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.92, 1.34]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.241295% CI: [0.79, 1.03]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.665295% CI: [0.91, 1.18]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.027595% CI: [0.75, 0.98]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.93, 1.21]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.241295% CI: [0.76, 1.06]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.312195% CI: [0.96, 1.32]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.038795% CI: [0.72, 0.99]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.841495% CI: [0.89, 1.22]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 0.54 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 0.59 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 0.49 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 0.51 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Infant Series | 0.58 mcg/mL |
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.81395% CI: [0.71, 1.22]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.84595% CI: [0.79, 1.34]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.46195% CI: [0.65, 1.11]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.54595% CI: [0.68, 1.16]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mcg/mL and corresponding 2-sided 95% CIs were evaluated for Hib PRP antibody.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose | 9.65 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose | 9.35 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose | 8.25 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose | 7.84 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) Antibody 1 Month After the Toddler Dose | 8.96 mcg/mL |
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.81, 1.43]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.79, 1.37]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86895% CI: [0.7, 1.21]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91495% CI: [0.67, 1.15]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in milli international units/mL (mIU/mL) and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 756.42 mIU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 770.93 mIU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 689.34 mIU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 599.12 mIU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Infant Series | 733.29 mIU/mL |
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.75, 1.42]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.83795% CI: [0.77, 1.44]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.69595% CI: [0.69, 1.28]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.40895% CI: [0.6, 1.12]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in mIU/mL and corresponding 2-sided 95% CIs were evaluated for hepatitis B virus (HBV) antibody.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose | 4868.61 mIU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose | 4148.04 mIU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose | 4250.41 mIU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose | 4263.28 mIU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Hepatitis B Virus (HBV) Antibody 1 Month After the Toddler Dose | 3866.37 mIU/mL |
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86995% CI: [0.9, 1.76]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.78, 1.48]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86895% CI: [0.8, 1.52]General Linear Model
Comparison: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91695% CI: [0.8, 1.52]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in EU/mL and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PT | 77.43 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PRN | 158.28 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis FHA | 115.55 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis FHA | 117.87 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PT | 76.93 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PRN | 156.98 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis FHA | 123.56 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PT | 73.72 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PRN | 160.96 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PT | 73.38 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PRN | 158.71 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis FHA | 108.11 EU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis FHA | 117.01 EU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PT | 74.01 EU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibodies 1 Month After the Toddler Dose | Pertussis PRN | 172.80 EU/mL |
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.89, 1.23]General Linear Model
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.89, 1.22]General Linear Model
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.96195% CI: [0.85, 1.16]General Linear Model
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91695% CI: [0.85, 1.16]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.87, 1.12]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.90995% CI: [0.89, 1.14]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86895% CI: [0.93, 1.2]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91495% CI: [0.81, 1.05]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.76, 1.11]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.76, 1.09]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86895% CI: [0.78, 1.12]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91495% CI: [0.76, 1.1]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in Enzyme-linked Immunosorbent Assay (ELISA) units/mL (EU/mL) and corresponding 2-sided 95% CIs were evaluated for pertussis (pertussis toxin \[PT\], filamentous hemagglutinin \[FHA\] and pertactin \[PRN\]) antibodies.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PT | 40.86 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PRN | 72.90 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis FHA | 46.29 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis FHA | 40.65 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PT | 43.51 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PRN | 71.26 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis FHA | 41.32 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PT | 40.27 EU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PRN | 65.82 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PT | 39.26 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PRN | 68.53 EU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis FHA | 35.55 EU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis FHA | 48.42 EU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PT | 44.85 EU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antibody 1 Month After the Infant Series | Pertussis PRN | 84.57 EU/mL |
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.71295% CI: [0.79, 1.06]General Linear Model
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.83795% CI: [0.84, 1.12]General Linear Model
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.35795% CI: [0.78, 1.04]General Linear Model
Comparison: Pertussis PT: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.1995% CI: [0.76, 1.01]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.81395% CI: [0.83, 1.1]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.13695% CI: [0.73, 0.96]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.10495% CI: [0.74, 0.98]General Linear Model
Comparison: Pertussis FHA: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: <0.00195% CI: [0.64, 0.85]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.71295% CI: [0.72, 1.04]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.20695% CI: [0.7, 1.01]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.06695% CI: [0.65, 0.93]General Linear Model
Comparison: Pertussis PRN: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.08595% CI: [0.67, 0.97]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured in IU/mL and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Tetanus | 2.54 IU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Diphtheria | 1.64 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Tetanus | 2.50 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Diphtheria | 1.94 IU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Tetanus | 2.60 IU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Diphtheria | 1.69 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Diphtheria | 1.87 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Tetanus | 2.29 IU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Tetanus | 2.66 IU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibodies 1 Month After the Toddler Dose | Diphtheria | 1.90 IU/mL |
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.83, 1.1]General Linear Model
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.82, 1.07]General Linear Model
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.93995% CI: [0.86, 1.12]General Linear Model
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.27995% CI: [0.75, 0.98]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.14995% CI: [0.76, 0.97]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.91, 1.14]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.39495% CI: [0.79, 0.99]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91695% CI: [0.87, 1.1]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series
Geometric LS mean concentration (GMCs) were measured in International Units/mL (IU/mL) and corresponding 2-sided 95% CIs were evaluated for tetanus and diphtheria antibodies.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies participants with a determinate antibody concentration to the given concomitant vaccine antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Tetanus | 0.73 IU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Diphtheria | 0.62 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Tetanus | 0.70 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Diphtheria | 0.68 IU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Tetanus | 0.69 IU/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Diphtheria | 0.61 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Diphtheria | 0.65 IU/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Tetanus | 0.60 IU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Tetanus | 0.82 IU/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Antigen-specific Tetanus and Diphtheria Antibody 1 Month After the Infant Series | Diphtheria | 0.65 IU/mL |
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.71295% CI: [0.77, 1.06]General Linear Model
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.20695% CI: [0.74, 1]General Linear Model
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.10495% CI: [0.72, 0.98]General Linear Model
Comparison: Tetanus: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.00195% CI: [0.63, 0.87]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.81395% CI: [0.82, 1.09]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.83795% CI: [0.9, 1.19]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.53495% CI: [0.81, 1.07]General Linear Model
Comparison: Diphtheria: Ratio of GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.96195% CI: [0.87, 1.15]General Linear Model
Secondary
Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose
Antibody geometric LS mean concentrations (GMCs) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% CI were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity set: eligible participants who had \>=1 valid,determinate assay result, 56-98 days of age at Vaccination 1, received antipyretic regimen as per randomization, received all vaccinations, may have had received additional anti-pyretic medication, had blood drawn within specified time frames, had no major protocol violations.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 (n = 130, 144, 143, 139, 206) | 2.80 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A (n = 130, 144, 143, 139, 206) | 5.12 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 (n = 130, 144, 143, 139, 206) | 8.10 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F (n = 130, 144, 142, 139, 206) | 3.79 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A (n = 129, 144, 142, 139, 206) | 7.11 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V (n = 130, 144, 143, 139, 206) | 2.15 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 (n = 130, 144, 143, 139, 206) | 2.33 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C (n = 130, 144, 143, 139, 206) | 1.35 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 (n = 130, 144, 143, 139, 206) | 3.07 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B (n = 130, 144, 143, 139, 206) | 6.70 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F (n = 130, 144, 142, 139, 206) | 2.34 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 (n = 129, 144, 143, 138, 203) | 0.46 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F (n = 130, 144, 143, 139, 206) | 8.41 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A (n = 130, 144, 143, 139, 206) | 5.73 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B (n = 130, 144, 143, 139, 206) | 8.01 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 (n = 130, 144, 143, 139, 206) | 3.22 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F (n = 130, 144, 142, 139, 206) | 2.96 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 (n = 130, 144, 143, 139, 206) | 3.43 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F (n = 130, 144, 142, 139, 206) | 3.89 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V (n = 130, 144, 143, 139, 206) | 2.23 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A (n = 129, 144, 142, 139, 206) | 7.99 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F (n = 130, 144, 143, 139, 206) | 8.99 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 (n = 130, 144, 143, 139, 206) | 8.40 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 (n = 130, 144, 143, 139, 206) | 2.75 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C (n = 130, 144, 143, 139, 206) | 1.68 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 (n = 129, 144, 143, 138, 203) | 0.54 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F (n = 130, 144, 142, 139, 206) | 2.37 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 (n = 130, 144, 143, 139, 206) | 2.97 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B (n = 130, 144, 143, 139, 206) | 6.38 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V (n = 130, 144, 143, 139, 206) | 2.17 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 (n = 130, 144, 143, 139, 206) | 7.95 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C (n = 130, 144, 143, 139, 206) | 1.36 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F (n = 130, 144, 143, 139, 206) | 7.53 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 (n = 130, 144, 143, 139, 206) | 2.66 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 (n = 129, 144, 143, 138, 203) | 0.46 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 (n = 130, 144, 143, 139, 206) | 2.40 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A (n = 130, 144, 143, 139, 206) | 5.27 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F (n = 130, 144, 142, 139, 206) | 3.56 mcg/mL |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A (n = 129, 144, 142, 139, 206) | 7.31 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 (n = 130, 144, 143, 139, 206) | 9.12 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A (n = 130, 144, 143, 139, 206) | 5.36 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 (n = 130, 144, 143, 139, 206) | 3.43 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 (n = 130, 144, 143, 139, 206) | 2.62 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B (n = 130, 144, 143, 139, 206) | 7.30 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A (n = 129, 144, 142, 139, 206) | 7.35 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F (n = 130, 144, 142, 139, 206) | 3.97 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F (n = 130, 144, 142, 139, 206) | 2.86 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C (n = 130, 144, 143, 139, 206) | 1.63 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 (n = 129, 144, 143, 138, 203) | 0.49 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F (n = 130, 144, 143, 139, 206) | 8.02 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V (n = 130, 144, 143, 139, 206) | 2.12 mcg/mL |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 (n = 130, 144, 143, 139, 206) | 3.12 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19A (n = 129, 144, 142, 139, 206) | 7.71 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 18C (n = 130, 144, 143, 139, 206) | 1.59 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 4 (n = 130, 144, 143, 139, 206) | 3.10 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 3 (n = 129, 144, 143, 138, 203) | 0.54 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 14 (n = 130, 144, 143, 139, 206) | 9.10 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 5 (n = 130, 144, 143, 139, 206) | 2.84 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 9V (n = 130, 144, 143, 139, 206) | 2.16 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 1 (n = 130, 144, 143, 139, 206) | 3.04 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6A (n = 130, 144, 143, 139, 206) | 5.52 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 6B (n = 130, 144, 143, 139, 206) | 7.08 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 23F (n = 130, 144, 142, 139, 206) | 2.75 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 19F (n = 130, 144, 143, 139, 206) | 7.95 mcg/mL |
| 13vPnC + INFANRIX Hexa | Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After the Toddler Dose | 7F (n = 130, 144, 142, 139, 206) | 3.98 mcg/mL |
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.93595% CI: [0.82, 1.19]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.93, 1.32]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.692295% CI: [0.8, 1.14]General Linear Model
Comparison: Serotype 4: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.93, 1.32]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.691595% CI: [0.78, 1.15]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.94, 1.36]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.438995% CI: [0.75, 1.09]General Linear Model
Comparison: Serotype 6B: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.85, 1.24]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.93595% CI: [0.87, 1.14]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.9, 1.18]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.94395% CI: [0.88, 1.15]General Linear Model
Comparison: Serotype 9V: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.85, 1.12]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.516795% CI: [0.74, 1.06]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.78, 1.1]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.73, 1.04]General Linear Model
Comparison: Serotype 14: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.987295% CI: [0.84, 1.19]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.258295% CI: [0.73, 1]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.91, 1.23]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.74, 1]General Linear Model
Comparison: Serotype 18C: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.88, 1.2]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.691595% CI: [0.86, 1.3]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.93, 1.38]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.692295% CI: [0.78, 1.15]General Linear Model
Comparison: Serotype 19F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.987295% CI: [0.83, 1.23]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.360995% CI: [0.7, 1.04]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.89, 1.3]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.71, 1.05]General Linear Model
Comparison: Serotype 23F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.86, 1.26]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.630495% CI: [0.79, 1.08]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.91, 1.24]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.75, 1.03]General Linear Model
Comparison: Serotype 1: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.88, 1.2]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.258295% CI: [0.71, 1.01]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.927995% CI: [0.84, 1.18]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.72, 1.01]General Linear Model
Comparison: Serotype 3: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.76, 1.07]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.142495% CI: [0.71, 0.96]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.84, 1.12]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.73, 0.98]General Linear Model
Comparison: Serotype 5: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.79, 1.07]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.630495% CI: [0.78, 1.1]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.88, 1.22]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.692295% CI: [0.81, 1.13]General Linear Model
Comparison: Serotype 6A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.82, 1.15]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.657295% CI: [0.84, 1.08]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.86, 1.11]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.251495% CI: [0.79, 1.01]General Linear Model
Comparison: Serotype 7F: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.987295% CI: [0.88, 1.13]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.630495% CI: [0.78, 1.09]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.791895% CI: [0.88, 1.22]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.692295% CI: [0.8, 1.12]General Linear Model
Comparison: Serotype 19A: Ratio of IgG GMCs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.976595% CI: [0.81, 1.13]General Linear Model
Secondary
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series
Geometric LS mean concentrations (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 1 | 68.11 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 3 | 246.22 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 2 | 79.60 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 2 | 73.52 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 1 | 66.59 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 3 | 184.03 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 2 | 62.12 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 1 | 67.43 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 3 | 257.92 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 1 | 70.66 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 3 | 218.85 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 2 | 55.17 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 2 | 67.37 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 1 | 72.02 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Infant Series | Poliomyelitis Type 3 | 231.02 titer |
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.81395% CI: [0.69, 1.3]General Linear Model
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.83795% CI: [0.68, 1.25]General Linear Model
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.69595% CI: [0.68, 1.28]General Linear Model
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.96195% CI: [0.71, 1.36]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.80895% CI: [0.85, 1.65]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.83795% CI: [0.8, 1.5]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.69595% CI: [0.66, 1.28]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.40895% CI: [0.58, 1.15]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.81395% CI: [0.78, 1.46]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.34395% CI: [0.59, 1.08]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.69595% CI: [0.82, 1.52]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.92595% CI: [0.69, 1.31]General Linear Model
Secondary
Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose
Geometric LS mean concentration (GMCs) were measured as titers and corresponding 2-sided 95% CIs were evaluated for poliomyelitis type 1, 2 and 3 antibodies.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 1 | 399.56 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 3 | 1205.80 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 2 | 613.18 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 2 | 586.30 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 1 | 426.63 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 3 | 1045.57 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 2 | 587.56 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 1 | 443.97 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 3 | 1210.29 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 1 | 415.45 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 3 | 1187.11 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 2 | 605.78 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 2 | 621.07 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 1 | 406.37 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Antigen-specific Poliomyelitis Type 1, 2 and 3 Antibodies 1 Month After the Toddler Dose | Poliomyelitis Type 3 | 1237.86 titer |
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.78, 1.24]General Linear Model
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.83, 1.32]General Linear Model
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86895% CI: [0.87, 1.37]General Linear Model
Comparison: Poliomyelitis Type 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91695% CI: [0.81, 1.28]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.79, 1.23]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.76, 1.17]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.86895% CI: [0.77, 1.17]General Linear Model
Comparison: Poliomyelitis Type 2: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91695% CI: [0.79, 1.21]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.9195% CI: [0.77, 1.23]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.8595% CI: [0.67, 1.06]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.93995% CI: [0.78, 1.23]General Linear Model
Comparison: Poliomyelitis Type 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.91695% CI: [0.76, 1.21]General Linear Model
Secondary
Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series
Antibody-mediated serum OPA against the 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) was measured centrally using a pneumococcal OPA assay. Results were expressed as OPA titers. OPA titers were logarithmically transformed for analysis; geometric means calculated and expressed as geometric mean titers (GMTs).
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate OPA titer to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 12 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 1060 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 435 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 1766 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 185 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 120 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 86 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 1094 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 1269 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 794 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 342 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 72 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 346 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 1681 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 655 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 11 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 441 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 1135 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 1907 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 166 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 257 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 221 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 622 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 96 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 853 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 76 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 332 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 1240 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 470 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 93 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 650 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 877 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 165 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 8 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 56 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 54 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 1228 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 1747 titer |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 163 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 991 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 1281 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 1361 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 99 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 663 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 159 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 1584 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 321 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 1031 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 62 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 294 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 285 titer |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 8 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 240 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 1092 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 1086 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 87 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 951 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 76 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 241 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 12 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 1462 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 748 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 366 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 279 titer |
| 13vPnC + INFANRIX Hexa | Geometric Mean Titer (GMT) for Serotype-specific Pneumococcal Opsonophagocytic Activity (OPA) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 2125 titer |
Comparison: Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.714895% CI: [0.82, 1.66]General Linear Model
Comparison: Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.790795% CI: [0.75, 1.45]General Linear Model
Comparison: Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.476595% CI: [0.81, 1.6]General Linear Model
Comparison: Serotype 4: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.503795% CI: [0.89, 1.76]General Linear Model
Comparison: Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.941495% CI: [0.52, 2.17]General Linear Model
Comparison: Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.790795% CI: [0.45, 1.71]General Linear Model
Comparison: Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.2995% CI: [0.32, 1.23]General Linear Model
Comparison: Serotype 6B: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.44, 1.77]General Linear Model
Comparison: Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.582395% CI: [0.18, 1.4]General Linear Model
Comparison: Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.27, 1.8]General Linear Model
Comparison: Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.240795% CI: [0.14, 1.05]General Linear Model
Comparison: Serotype 9V: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.43, 3.22]General Linear Model
Comparison: Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.096195% CI: [0.26, 0.81]General Linear Model
Comparison: Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.38, 1.11]General Linear Model
Comparison: Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.2995% CI: [0.39, 1.19]General Linear Model
Comparison: Serotype 14: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.6, 1.82]General Linear Model
Comparison: Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.992595% CI: [0.65, 1.54]General Linear Model
Comparison: Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.52, 1.17]General Linear Model
Comparison: Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.392995% CI: [0.53, 1.22]General Linear Model
Comparison: Serotype 18C: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.62, 1.43]General Linear Model
Comparison: Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.743395% CI: [0.7, 2.2]General Linear Model
Comparison: Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.46, 1.35]General Linear Model
Comparison: Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.240795% CI: [0.34, 1.03]General Linear Model
Comparison: Serotype 19F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.61, 1.83]General Linear Model
Comparison: Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.941495% CI: [0.51, 1.71]General Linear Model
Comparison: Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.68, 2.14]General Linear Model
Comparison: Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.73895% CI: [0.5, 1.63]General Linear Model
Comparison: Serotype 23F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.49, 1.58]General Linear Model
Comparison: Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.941495% CI: [0.67, 1.65]General Linear Model
Comparison: Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.790795% CI: [0.58, 1.43]General Linear Model
Comparison: Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.240795% CI: [0.43, 1.04]General Linear Model
Comparison: Serotype 1: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.26795% CI: [0.42, 1.02]General Linear Model
Comparison: Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.582395% CI: [0.62, 1.11]General Linear Model
Comparison: Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.65, 1.16]General Linear Model
Comparison: Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.042295% CI: [0.48, 0.86]General Linear Model
Comparison: Serotype 3: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.26795% CI: [0.53, 0.96]General Linear Model
Comparison: Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.845495% CI: [0.72, 1.78]General Linear Model
Comparison: Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.81, 2]General Linear Model
Comparison: Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.282495% CI: [0.45, 1.11]General Linear Model
Comparison: Serotype 5: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.515595% CI: [0.83, 2.06]General Linear Model
Comparison: Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.582395% CI: [0.5, 1.06]General Linear Model
Comparison: Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.78, 1.7]General Linear Model
Comparison: Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.464495% CI: [0.56, 1.25]General Linear Model
Comparison: Serotype 6A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.882695% CI: [0.59, 1.31]General Linear Model
Comparison: Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.582395% CI: [0.61, 1.13]General Linear Model
Comparison: Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.763695% CI: [0.65, 1.23]General Linear Model
Comparison: Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.329995% CI: [0.6, 1.13]General Linear Model
Comparison: Serotype 7F: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.26795% CI: [0.54, 1.03]General Linear Model
Comparison: Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.582395% CI: [0.48, 1.23]General Linear Model
Comparison: Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen twice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.790795% CI: [0.68, 1.69]General Linear Model
Comparison: Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Paracetamol thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.274295% CI: [0.43, 1.09]General Linear Model
Comparison: Serotype 19A: Ratio of GMTs along with 2-sided 95% CI were back transformed from the difference of the LS mean of 13vPnC + INFANRIX hexa + Ibuprofen thrice daily group minus the LS mean of 13vPnC + INFANRIX hexa group.p-value: 0.26795% CI: [0.42, 1.05]General Linear Model
Secondary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events after the infant series were events between 1 month (28 to 42 days) after infant series to toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs spontaneously collected on case report form (non-systematic assessment).
Time frame: 1 Month (28 to 42 days) after infant series Dose 3 up to toddler dose
Population: Safety analysis set Dose 3 included all participants who receive Dose 3 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | Non-SAEs | 3 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | SAEs | 6 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | Non-SAEs | 6 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | SAEs | 14 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | Non-SAEs | 3 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | SAEs | 10 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | SAEs | 11 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | Non-SAEs | 4 participants |
| 13vPnC + INFANRIX Hexa | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | Non-SAEs | 8 participants |
| 13vPnC + INFANRIX Hexa | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): After the Infant Series | SAEs | 9 participants |
Secondary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for infant series were events between infant series Dose 1 and up to 1 month (28 to 42 days) after infant series that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Time frame: Baseline up to 1 Month (28 to 42 days) after infant series
Population: Safety analysis set Dose 1 included all participants who receive Dose 1 of 13vPnC or INFANRIX hexa in infant series and had AE or temperature data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | Non-SAEs | 57 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | SAEs | 7 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | Non-SAEs | 71 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | SAEs | 3 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | Non-SAEs | 67 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | SAEs | 11 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | SAEs | 8 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | Non-SAEs | 72 participants |
| 13vPnC + INFANRIX Hexa | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | Non-SAEs | 80 participants |
| 13vPnC + INFANRIX Hexa | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Infant Series | SAEs | 10 participants |
Secondary
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose
An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. SAE: an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent events for toddler dose were events between toddler dose and up to 1 month (28 to 42 days) after toddler dose that were absent before treatment or that worsened relative to pre-treatment state. Reported non-SAEs included AEs other than SAEs collected using electronic diary (fever, systematic assessment) and events spontaneously collected on case report form at each visit (non-systematic assessment).
Time frame: Toddler dose up to 1 Month (28 to 42 days) after toddler dose
Population: Safety analysis set toddler dose included all participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | Non-SAEs | 47 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | SAEs | 3 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | Non-SAEs | 57 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | SAEs | 2 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | Non-SAEs | 52 participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | SAEs | 1 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | SAEs | 1 participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | Non-SAEs | 76 participants |
| 13vPnC + INFANRIX Hexa | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | Non-SAEs | 50 participants |
| 13vPnC + INFANRIX Hexa | Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs): Toddler Dose | SAEs | 1 participants |
Secondary
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate \[PRP\] \>=0.15 mcg/mL; Hib PRP \>=1 mcg/mL; Pertussis PT \>=14.6 EU/mL, FHA \>=16.1 EU/mL, PRN \>=24.0 EU/mL; Tetanus \>=0.1 IU/mL; Diphtheria \>=0.1 IU/mL; HBV \>=10 mIU/mL; Poliomyelitis Type 1, 2, 3 \>=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Tetanus >=0.1 IU/mL (n = 132,143,141,131,193) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198) | 87.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135) | 97.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193) | 96.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135) | 95.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193) | 93.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | HBV >= 10mIU/mL (n = 105,116,120,112,156) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193) | 90.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198) | 33.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193) | 87.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193) | 98.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Tetanus >=0.1 IU/mL (n = 132,143,141,131,193) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198) | 37.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198) | 84.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135) | 98.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193) | 97.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135) | 98.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193) | 92.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | HBV >= 10mIU/mL (n = 105,116,120,112,156) | 99.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Tetanus >=0.1 IU/mL (n = 132,143,141,131,193) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198) | 86.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198) | 27.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193) | 91.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193) | 93.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193) | 88.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | HBV >= 10mIU/mL (n = 105,116,120,112,156) | 99.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135) | 97.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135) | 95.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135) | 98.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193) | 88.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198) | 85.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198) | 28.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135) | 98.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135) | 96.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193) | 90.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Tetanus >=0.1 IU/mL (n = 132,143,141,131,193) | 98.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | HBV >= 10mIU/mL (n = 105,116,120,112,156) | 99.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193) | 89.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193) | 97.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=0.15 mcg/mL (n= 136, 146, 144, 139, 198) | 87.9 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Diphtheria >=0.1 IU/mL (n = 132,143,141,131,193) | 99.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis FHA >=16.1 EU/mL (n=132,143,141,131,193) | 95.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | HBV >= 10mIU/mL (n = 105,116,120,112,156) | 98.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PT >=14.6 EU/mL (n= 132,143,141,131,193) | 95.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType3 >=1:8titer (n=89,105,93,84,135) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType1 >=1:8titer (n=89,105,93,84,135) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Hib PRP >=1 mcg/mL (n = 136, 146, 144, 139, 198) | 33.8 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | PoliomyelitisType2 >=1:8titer (n=89,105,93,84,135) | 95.6 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Tetanus >=0.1 IU/mL (n = 132,143,141,131,193) | 99.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Infant Series | Pertussis PRN >=24.0 EU/mL (n=132,143,141,131,193) | 95.3 percentage of participants |
Secondary
Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose
Percentage of participants achieving pre-specified criteria for concomitant antigens contained in INFANRIX hexa (Hib polyribosylribitol phosphate \[PRP\] \>=0.15 mcg/mL; Hib PRP \>=1 mcg/mL; Pertussis PT \>=14.8 EU/mL, FHA \>=46.5 EU/mL, PRN \>=43.5 EU/mL; Tetanus \>=0.1 IU/mL; Diphtheria \>=0.1 IU/mL; HBV \>=10 mIU/mL; Poliomyelitis Type 1, 2, 3 \>=1:8 titer) along with the corresponding 95% CIs were presented. Exact 2-sided CI based on the observed proportion of participants. Pre-specified criteria for pertussis was the level that 95% of the participants achieved in 13vPnC + INFANRIX hexa group.
Time frame: 1 month after the toddler dose
Population: mITT toddler immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate antibody concentration or titer to the given concomitant vaccine antigen for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Tetanus >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201) | 99.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199) | 91.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199) | 97.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | HBV >= 10 mIU/mL (n = 119,131,133,133,191) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199) | 91.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202) | 95.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199) | 94.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Tetanus >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202) | 96.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199) | 94.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | HBV >= 10 mIU/mL (n = 119,131,133,133,191) | 98.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Tetanus >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202) | 95.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199) | 98.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199) | 93.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199) | 94.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | HBV >= 10 mIU/mL (n = 119,131,133,133,191) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199) | 92.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202) | 95.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Tetanus >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | HBV >= 10 mIU/mL (n = 119,131,133,133,191) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199) | 94.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=0.15 mcg/mL (n= 126, 135, 141, 138, 202) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Diphtheria >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis FHA >=46.5 EU/mL (n=123,137,141,136,199) | 95.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | HBV >= 10 mIU/mL (n = 119,131,133,133,191) | 99.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PT >=14.8 EU/mL (n= 123,137,141,136,199) | 95.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 3 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 1 >=1:8titer (n=123,133,141,136,201) | 99.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Hib PRP >=1 mcg/mL (n = 126, 135, 141, 138, 202) | 95.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Poliomyelitis 2 >=1:8titer (n=123,133,141,136,201) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Tetanus >=0.1 IU/mL (n = 123,137,141,136,199) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Pre-specified Criteria for the Concomitant Antigens Contained in INFANRIX Hexa 1 Month After the Toddler Dose | Pertussis PRN >=43.5 EU/mL (n=123,137,141,136,199) | 95.5 percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series
Percentage of participants achieving predefined antibody threshold \>=0.35 mcg/mL along with the corresponding 95% confidence interval (CI) for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 94.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 86.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 98.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 96.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 84.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 23F (n = 137, 155, 148, 146, 210) | 86.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 96.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 94.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 72.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 83.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 97.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 97.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 99.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 23F (n = 137, 155, 148, 146, 210) | 90.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 80.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 99.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 92.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 99.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 97.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 91.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 98.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 89.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 97.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 99.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 61.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 96.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 95.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 95.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 95.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 23F (n = 137, 155, 148, 146, 210) | 74.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 90.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 81.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 76.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 83.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 97.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 98.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 94.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 95.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 88.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 98.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 97.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 89.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 95.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 91.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 79.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 99.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 23F (n = 137, 155, 148, 146, 210) | 88.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 96.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6B (n = 136, 155, 148, 146, 210) | 77.6 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 1 (n = 138, 155, 148, 147, 210) | 94.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19A (n = 137, 155, 148, 146, 210) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 14 (n = 138, 155, 148, 147, 210) | 99.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 4 (n = 137, 155, 148, 146, 210) | 98.1 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 23F (n = 137, 155, 148, 146, 210) | 88.1 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 3 (n = 138, 155, 148, 147, 210) | 91.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 6A (n = 138, 155, 148, 146, 210) | 91.9 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 9V (n = 138, 155, 148, 147, 210) | 96.2 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 18C (n = 138, 155, 148, 147, 210) | 96.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 7F (n = 138, 155, 148, 146, 210) | 99.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 5 (n = 137, 155, 148, 146, 210) | 84.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody Level Greater Than or Equal to (>=)0.35 Microgram Per Milliliter (Mcg/mL) 1 Month After the Infant Series | 19F (n = 138, 155, 148, 147, 210) | 97.6 percentage of participants |
Secondary
Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series
Percentage of participants achieving serotype-specific pneumococcal OPA titer \>= LLOQ, along with the corresponding 95% CIs for 13 pneumococcal serotypes (4, 6B, 9V, 14, 18C, 19F, 23F, 1, 3, 5, 6A, 7F and 19A) are presented. Exact 2-sided CI based on the observed proportion of participants. The OPA LLOQ in titers for each serotype: 1 = 1:18; 3 = 1:12; 4 = 1:21; 5 = 1:29; 6A = 1:37; 6B = 1:43; 7F = 1:210; 9V = 1:345; 14 = 1:35; 18C = 1:31; 19A = 1:18; 19F = 1:48; 23F = 1:13.
Time frame: 1 month after the infant series
Population: mITT infant immunogenicity population. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure and 'n' signifies participants with a determinate IgG concentration to the given serotype for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 47.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 93.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 89.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 92.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 62.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 92.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 94.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 92.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 97.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 97.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 88.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 42.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 97.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 66.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 87.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 97.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 90.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 95.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 97.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 92.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 88.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 59.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 90.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 30.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 97.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 86.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 90.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 97.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 92.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 92.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 88.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 97.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 90.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 97.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 94.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 92.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 80.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 29.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19A (n = 42, 44, 41, 42, 74) | 97.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 18C (n = 37, 47, 41, 41, 62) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 4 (n = 37, 46, 42, 41, 61) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 3 (n = 41, 41, 39, 39, 69) | 100.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 14 (n = 38, 48, 41, 41, 64) | 96.9 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 5 (n = 42, 43, 44, 42, 73) | 86.3 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 9V (n = 37, 48, 42, 41, 65) | 75.4 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 1 (n = 42, 42, 43, 44, 74) | 45.9 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6A (n = 46, 42, 39, 39, 76) | 98.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 6B (n = 36, 45, 43, 40, 62) | 96.8 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 23F (n = 38, 45, 42, 42, 63) | 93.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 19F (n = 37, 46, 41, 42, 63) | 95.2 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Achieving Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Titers Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ) 1 Month After the Infant Series | 7F (n = 46, 42, 40, 39, 76) | 100.0 percentage of participants |
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1
Participants' core (rectal) temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree Celsius (degree C), greater than (\>) 39 but \<=40 degree C and \>40 degree C.
Time frame: Within 4 days after infant series Dose 1
Population: Safety analysis set Dose 1: participants who received Dose 1 of 13vPnC/INFANRIX hexa in infant series, had Adverse Event (AE) or temperature data. 'N'(number of participants analyzed)=participants reported yes for \>=1 day or no for all days, 'n'=participants reporting yes for \>=1 day or no for all days for specified event for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >=38, <=39 degree C (n= 149,157,147,155,187) | 32.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >40 degree C (n = 138,145,137,146,170) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >39, <=40 degree C (n = 138,145,137,146,170) | 1.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >39, <=40 degree C (n = 138,145,137,146,170) | 1.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >=38, <=39 degree C (n= 149,157,147,155,187) | 45.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >40 degree C (n = 138,145,137,146,170) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >39, <=40 degree C (n = 138,145,137,146,170) | 0.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >=38, <=39 degree C (n= 149,157,147,155,187) | 18.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >40 degree C (n = 138,145,137,146,170) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >=38, <=39 degree C (n= 149,157,147,155,187) | 34.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >40 degree C (n = 138,145,137,146,170) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >39, <=40 degree C (n = 138,145,137,146,170) | 0.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >39, <=40 degree C (n = 138,145,137,146,170) | 1.2 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >=38, <=39 degree C (n= 149,157,147,155,187) | 41.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 1 | Fever >40 degree C (n = 138,145,137,146,170) | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C.
Time frame: Within 4 days after infant series Dose 2
Population: Safety analysis set Dose 2: participants who received Dose 2 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for \>=1 day or no for all days, 'n'=participants reporting yes for \>=1 day or no for all days for specified event for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >=38, <=39 degree C (n= 141,152,140,159,181) | 26.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >40 degree C (n = 131,140,133,144,164) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >39, <=40 degree C (n = 133,140,134,145,164) | 1.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >39, <=40 degree C (n = 133,140,134,145,164) | 0.7 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >=38, <=39 degree C (n= 141,152,140,159,181) | 42.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >40 degree C (n = 131,140,133,144,164) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >39, <=40 degree C (n = 133,140,134,145,164) | 1.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >=38, <=39 degree C (n= 141,152,140,159,181) | 21.4 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >40 degree C (n = 131,140,133,144,164) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >=38, <=39 degree C (n= 141,152,140,159,181) | 44.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >40 degree C (n = 131,140,133,144,164) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >39, <=40 degree C (n = 133,140,134,145,164) | 1.4 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >39, <=40 degree C (n = 133,140,134,145,164) | 3.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >=38, <=39 degree C (n= 141,152,140,159,181) | 39.8 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 2 | Fever >40 degree C (n = 131,140,133,144,164) | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C. Report of fever \>40 degrees C after 13vPnC Infant Series Dose 3 was confirmed as data entry error.
Time frame: Within 4 days after infant series Dose 3
Population: Safety analysis set Dose 3: participants who received Dose 3 of 13vPnC/INFANRIX hexa in infant series and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for \>=1 day or no for all days, 'n'=participants reporting yes for \>=1 day or no for all days for specified event for each arm respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >=38, <=39 degree C (n= 136,146,135,141,175) | 22.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >40 degree C (n = 128,136,126,135,166) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >39, <=40 degree C (n = 129,137,125,136,167) | 1.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >39, <=40 degree C (n = 129,137,125,136,167) | 2.9 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >=38, <=39 degree C (n= 136,146,135,141,175) | 30.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >40 degree C (n = 128,136,126,135,166) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >39, <=40 degree C (n = 129,137,125,136,167) | 0.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >=38, <=39 degree C (n= 136,146,135,141,175) | 17.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >40 degree C (n = 128,136,126,135,166) | 0.8 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >=38, <=39 degree C (n= 136,146,135,141,175) | 33.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >40 degree C (n = 128,136,126,135,166) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >39, <=40 degree C (n = 129,137,125,136,167) | 1.5 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >39, <=40 degree C (n = 129,137,125,136,167) | 1.8 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >=38, <=39 degree C (n= 136,146,135,141,175) | 29.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Infant Series Dose 3 | Fever >40 degree C (n = 128,136,126,135,166) | 0.0 percentage of participants |
Secondary
Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose
Participants' rectal temperature was collected for 4 days after each vaccination using an electronic diary. Participants' temperature was collected at 6 to 8 hours after vaccination, 6 to 8 hours following that and coincidentally with antipyretic administration for groups receiving antipyretics. Temperature was recorded at bedtime daily for 3 following days (Day 2 to Day 4) and at any time during the 3 days when fever was suspected. The highest temperature for each day was recorded in the e-diary. Incidences of fever were presented in following categories: \>=38 but \<=39 degree C, \>39 but \<=40 degree C and \>40 degree C.
Time frame: Within 4 days after toddler dose
Population: Safety analysis set toddler dose: participants who receive toddler dose of 13vPnC or INFANRIX hexa and had AE or temperature data available. 'N' (number of participants analyzed) =participants reported yes for \>=1 day or no for all days, 'n' =participants reporting yes for \>=1 day or no for all days for specified event for each arm, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >=38, <=39 degree C (n= 133,140,134,144,162) | 31.6 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >40 degree C (n = 123,125,117,122,150) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >39, <=40 degree C (n = 128,127,118,123,150) | 5.5 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >39, <=40 degree C (n = 128,127,118,123,150) | 7.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >=38, <=39 degree C (n= 133,140,134,144,162) | 37.1 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >40 degree C (n = 123,125,117,122,150) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >39, <=40 degree C (n = 128,127,118,123,150) | 4.2 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >=38, <=39 degree C (n= 133,140,134,144,162) | 37.3 percentage of participants |
| 13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >40 degree C (n = 123,125,117,122,150) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >=38, <=39 degree C (n= 133,140,134,144,162) | 50.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >40 degree C (n = 123,125,117,122,150) | 0.0 percentage of participants |
| 13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >39, <=40 degree C (n = 128,127,118,123,150) | 5.7 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >39, <=40 degree C (n = 128,127,118,123,150) | 2.0 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >=38, <=39 degree C (n= 133,140,134,144,162) | 30.2 percentage of participants |
| 13vPnC + INFANRIX Hexa | Percentage of Participants Reporting Fever Within 4 Days: Toddler Dose | Fever >40 degree C (n = 123,125,117,122,150) | 0.0 percentage of participants |