Bacterial Infections, Virus Diseases
Conditions
Keywords
combination vaccine, diphtheria, pertussis, tetanus, hepatitis B, Hep B, Haemophilus influenzae b, Hib, polio, poliovirus
Brief summary
This study will determine whether participants who receive the vaccine V419 at 2, 3, 4, and 12 months of age have an acceptable immune response to the vaccine. The study will also determine whether the immune response to V419 is similar to that of participants who receive a licensed vaccine control.
Interventions
BIOLOGICALV419
V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate \[Meningococcal Outer Membrane Protein Complex\], and Hepatitis B \[Recombinant\] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
BIOLOGICALINFANRIX™ hexa
INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
BIOLOGICALRotaTeq
RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
BIOLOGICALPrevenar 13
Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
BIOLOGICALProQuad™
ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
Sponsors
Merck Sharp & Dohme LLC
MCM Vaccines B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
46 Days to 74 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants able to attend all study visits * Parent(s)/legal representative able to read, understand, and complete study questionnaires
Exclusion criteria
* History of congenital or acquired immunodeficiency * Received or is expected to receive immunosuppressive agents or systemic immunomodulatory steroids * History of leukemia, lymphoma, malignant melanoma, or myeloproliferative disorder * Hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines or concomitant study vaccines * Has any chronic illness that could interfere with study conduct or completion * Received any immune globulin, blood, or blood-derived products since birth * Received a dose of hepatitis B vaccine prior to the study * Vaccinated with any acellular pertussis or whole cell pertussis based combination vaccines, Haemophilus influenzae type b conjugate, poliovirus, pneumococcal conjugate or pneumococcal polysaccharide, rotavirus, measles, mumps, rubella, or varicella vaccines, or any combination thereof * Fever within 24 hours prior to enrollment * Received any non-study vaccine within 30 days prior to enrollment, except for inactivated influenza vaccine, which is permitted 14 days or more prior to enrollment * Has a coagulation disorder * Has developmental delay or neurological disorder * Participant or his/her mother has a medical history of hepatitis B surface antigen (HBsAg) seropositivity * History of measles, mumps, rubella, varicella, Haemophilus influenzae type B, hepatitis B, diphtheria, tetanus, pertussis, rotavirus, invasive pneumococcal, or poliomyelitis infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | One month after post-dose 3 of PRI5 (5 months old) | Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria & poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 & 3 (90%). |
| Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | One month after Toddler dose of PRI5 (13 months old) | Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria & poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 & 3 (FIM) & Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria & tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%). |
| Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | One month after post-dose 3 of PRI5 (5 months old) | Antibody titres were measured by RIA for PRP, MIT for diphtheria & poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country. |
| Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, & PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Day 1 to Day 15 after any vaccination | Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs |
| Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps & rubella, and 76% for varicella. |
| Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Day 1 to Day 5 after any vaccination | Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported. |
| Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | One month after Toddler dose of PRI5 (13 months old) | Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country. |
| Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | Day 1 to Day 15 after any vaccination | Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported. |
| Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Day 1 to Day 5 after any vaccination | Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). |
Participant flow
Recruitment details
Healthy infants 46 to 74 days old were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| PR5I The PR5I group received V419, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by V419 and ProQuad™ at 12 months, and Prevenar 13™ and ProQuad™ at 13 months. | 611 |
| INFANRIX™ Hexa The INFANRIX™ hexa group received INFANRIX™ hexa, Prevenar 13™, and RotaTeq™ at 2, 3, and 4 months; followed by INFANRIX™ hexa and ProQuad™ at 12 months; and Prevenar 13™ and ProQuad™ at 13 months. | 606 |
| Total | 1,217 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Infant Series | Adverse Event | 0 | 5 |
| Infant Series | Lost to Follow-up | 0 | 2 |
| Infant Series | Not Vaccinated | 0 | 1 |
| Infant Series | Protocol Violation | 1 | 0 |
| Infant Series | Site 0048 Participants | 17 | 16 |
| Infant Series | Withdrawal by Subject | 11 | 8 |
| Interim Period | Lost to Follow-up | 2 | 0 |
| Interim Period | Physician Decision | 0 | 1 |
| Interim Period | Protocol Violation | 0 | 1 |
| Interim Period | Withdrawal by Subject | 6 | 7 |
| Post-Treatment | Adverse Event | 0 | 2 |
| Post-Treatment | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | PR5I | INFANRIX™ Hexa | Total |
|---|---|---|---|
| Age, Continuous | 61.4 Days STANDARD_DEVIATION 6.9 | 61.5 Days STANDARD_DEVIATION 6.9 | 61.5 Days STANDARD_DEVIATION 6.9 |
| Sex: Female, Male Female | 291 Participants | 290 Participants | 581 Participants |
| Sex: Female, Male Male | 320 Participants | 316 Participants | 636 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 610 | 0 / 605 |
| other Total, other adverse events | 603 / 610 | 599 / 605 |
| serious Total, serious adverse events | 23 / 610 | 22 / 605 |
Outcome results
Primary
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old
Antibody titres were measured by ECi for HBsAg and ELISA for PT, FHA, & PRN. Percentage of participants with an Ab titre ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, and PRN are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Time frame: One month after Toddler dose of PRI5 (13 months old)
Population: All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-FHA seroresponse | 97.22 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-HBsAg ≥10 mIU/mL | 99.64 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-PRN seroresponse | 98.89 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-PT seroresponse | 99.82 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-PRN seroresponse | 98.86 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-PT seroresponse | 98.49 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-FHA seroresponse | 99.81 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response Rates to Hepatitis B and Seroresponse to Pertussis Antigens Pt, FHA and PRN One Month After the Toddler Dose at 13 Months Old | Anti-HBsAg ≥10 mIU/mL | 99.06 Percentage of participants |
Comparison: Difference in percentages: Non-inferiority for HBsAgp-value: <0.00195% CI: [-0.49, 1.85]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for PTp-value: <0.00195% CI: [0.32, 2.86]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for FHAp-value: <0.00195% CI: [-4.39, -1.29]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for PRNp-value: <0.00195% CI: [-1.4, 1.52]Miettinen & Nurminen
Primary
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Antibody titres were measured by RIA for PRP, MIT for diphtheria & poliovirus, and ELISA for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Hib) (PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Time frame: One month after post-dose 3 of PRI5 (5 months old)
Population: All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-PRP ≥0.15 μg/mL | 98.36 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-Diphtheria ≥0.01 IU/mL | 99.81 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-Tetanus ≥0.01 IU/mL | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV1 ≥8 (1/dil) | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV2 ≥8 (1/dil) | 99.82 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV3 ≥8 (1/dil) | 100 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV2 ≥8 (1/dil) | 99.62 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-PRP ≥0.15 μg/mL | 86.99 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV1 ≥8 (1/dil) | 99.81 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-Diphtheria ≥0.01 IU/mL | 99.81 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV3 ≥8 (1/dil) | 100 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-Tetanus ≥0.01 IU/mL | 100 Percentage of participants |
Comparison: Difference in percentages: Non-inferiority for PRPp-value: <0.00195% CI: [8.44, 14.68]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for Diphtheriap-value: <0.00195% CI: [-0.95, 0.96]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for Tetanusp-value: <0.00195% CI: [-0.71, 0.74]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for IPV1p-value: <0.00195% CI: [-0.51, 1.07]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for IPV2p-value: <0.00195% CI: [-0.69, 1.21]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for IPV3p-value: <0.00195% CI: [-0.7, 0.73]Miettinen & Nurminen
Primary
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months
Antibody titres in the PR5I group were measured by RIA for PRP, MIT for diphtheria & poliovirus, enhanced Chemiluminescence assay (ECi)) for Hepatitis B surface antigen (HBsAg) and ELISA for tetanus, Pertussis toxoid (PT), Filamentous haemagglutinin (FHA), Fimbriae types 2 & 3 (FIM) & Pertactin (PRN). Percentage of participants with an Ab titre ≥1.0 μg/mL for Hib (PRP); ≥0.1 IU/mL; for diphtheria & tetanus; ≥10 mIU/mL HBsAg; ≥8 (1/dil) for IPV1, 2 & 3, and seroresponse to PT, FHA, FIM and PRN are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the lower CI limits for PRP, PT, FHA, FIM, and PRN (75%); Diphtheria (80%); HBsAG, IPV 1, 2, 3 (90%).
Time frame: One month after Toddler dose of PRI5 (13 months old)
Population: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-PRP ≥1.0 μg/mL | 94.99 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-Diphtheria ≥0.1 IU/mL | 99.81 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-Tetanus ≥0.1 IU/mL | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-IPV1 ≥8 (1/dil) | 99.81 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-IPV2 ≥8 (1/dil) | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-IPV3 ≥8 (1/dil) | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-HBsAg ≥10 mIU/mL | 99.64 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-PT seroresponse | 99.82 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-FHA seroresponse | 97.23 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-FIM seroresponse | 99.61 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response or Seroresponse Rates to All Antigens Contained in the PR5I Vaccine One Month After the Toddler Dose at 13 Months | Anti-PRN seroresponse | 98.9 Percentage of participants |
Primary
Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months
Antibody titres in the PR5I group were measured by Radioimmunoassay (RIA) for Haemophilus influenzae type b (PRP), Micrometabolic inhibition test (MIT) for diphtheria & poliovirus, and Enzyme-Linked Immunosorbent Assay (ELISA) for tetanus. Percentage of participants with an Ab titre ≥0.15 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥0.01 IU/mL; for diphtheria & tetanus; ≥8 (1/dil) for inactivated poliovirus types 1, 2 & 3 (IPV1, 2 & 3) are reported. 95% confidence interval (CI) were calculated based on the exact binomial method by Clopper and Pearson. The immune response to PR5I vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits for PRP, diphtheria (80%), tetanus (90%), and IPV1, 2 & 3 (90%).
Time frame: One month after post-dose 3 of PRI5 (5 months old)
Population: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within revised windows (RW) of Days 28 to 51 Post-Dose 3. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-PRP ≥0.15 μg/mL | 98.36 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-Diphtheria ≥0.01 IU/mL | 99.82 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-Tetanus ≥0.01 IU/mL | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV1 ≥8 (1/dil) | 100 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV2 ≥8 (1/dil) | 99.82 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Antibody (Ab) Response to Haemophilus Influenzae Type b, Diphtheria, Tetanus, and Poliovirus Types 1, 2 & 3, at 5 Months | Anti-IPV3 ≥8 (1/dil) | 100 Percentage of participants |
Secondary
Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination
Solicited ISRs were defined as injection-site erythema, injection-site pain, and injection-site swelling occurring from Day 1 (D1) to Day 5 (D5) after vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)).
Time frame: Day 1 to Day 5 after any vaccination
Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Injection-site erythema | 69 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Injection-site pain | 73.6 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Injection-site swelling | 56.9 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Injection-site erythema | 64.2 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Injection-site pain | 71.8 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited ISRs From Day 1 to Day 5 After Any Vaccination | Injection-site swelling | 52.9 Percentage of participants |
Comparison: Risk difference: Injection-site erythema95% CI: [-0.5, 10.1]
Comparison: Risk difference: Injection-site pain95% CI: [-3.2, 6.8]
Comparison: Risk difference: Injection-site swelling95% CI: [-1.6, 9.6]
Secondary
Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination
Solicited systemic AEs were defined as crying, decreased appetite, irritability, pyrexia (rectal temperature ≥38.0°C), somnolence, and vomiting occurring from D1 to D5 after vaccination. The investigator assessed whether these systemic AEs were related or not to the vaccines. All (related and unrelated) AEs are reported.
Time frame: Day 1 to Day 5 after any vaccination
Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Crying | 85.4 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Decreased appetite | 63.9 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Irritability | 87.9 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Pyrexia | 71.5 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Somnolence | 76.9 Percentage of participants |
| PR5I | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Vomiting | 31.8 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Somnolence | 80.1 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Crying | 87.9 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Pyrexia | 73.1 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Decreased appetite | 67.0 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Vomiting | 31.0 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Solicited Systemic AE From Day 1 to Day 5 After Any Vaccination | Irritability | 85.7 Percentage of participants |
Comparison: Risk difference: Crying95% CI: [-6.3, 1.4]
Comparison: Risk difference: Decreased appetite95% CI: [-8.4, 2.3]
Comparison: Risk difference: Irritability95% CI: [-1.7, 6]
Comparison: Risk difference: Pyrexia95% CI: [-6.7, 3.4]
Comparison: Risk difference: Somnolence95% CI: [-7.8, 1.4]
Comparison: Risk difference: Vomiting95% CI: [-4.4, 6]
Secondary
Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination
Unsolicited ISRs with incidence ≥1% after any vaccination were reported daily on the VRC by the parent(s) or legal representative from (D1-D15). AEs at injection sites were always considered as vaccine-related ISRs
Time frame: Day 1 to Day 15 after any vaccination
Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site bruising | 2.8 Percentage of participants |
| PR5I | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site haematoma | 1.5 Percentage of participants |
| PR5I | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site haemorrhage | 1.3 Percentage of participants |
| PR5I | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site induration | 14.6 Percentage of participants |
| PR5I | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site nodule | 1.3 Percentage of participants |
| PR5I | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site warmth | 3.0 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site nodule | 1.5 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site bruising | 2.7 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site induration | 18.2 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site haematoma | 0.8 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site warmth | 1.8 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Reporting Unsolicited ISRs From Day 1 to Day 15 After Any Vaccination | Injection-site haemorrhage | 2.0 Percentage of participants |
Comparison: Risk difference: Injection-site bruising95% CI: [-1.8, 2.1]
Comparison: Risk difference: Injection-site haematoma95% CI: [-0.6, 2.1]
Comparison: Risk difference: Injection-site haemorrhage95% CI: [-2.3, 0.8]
Comparison: Risk difference: Injection-site induration95% CI: [-7.8, 0.5]
Comparison: Risk difference: Injection-site nodule95% CI: [-1.7, 1.3]
Comparison: Risk difference: Injection-site warmth95% CI: [-0.6, 3]
Secondary
Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. The estimated response rates are based on the method by Miettinen and Nurminen stratified by country.
Time frame: One month after Toddler dose of PRI5 (13 months old)
Population: All participants who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Measles ≥255 mIU/mL | 96.15 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Mumps ≥10 Ab units/mL | 94.86 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Rubella ≥10 IU/mL | 98.28 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Varicella ≥5 gpELISA units/mL | 97.64 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Varicella ≥5 gpELISA units/mL | 97.66 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Measles ≥255 mIU/mL | 96.41 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Rubella ≥10 IU/mL | 97.89 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants Vaccinated With PR5I Compared With INFANRIX™ Hexa With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Mumps ≥10 Ab units/mL | 91.78 Percentage of participants |
Comparison: Difference in percentages: Non-inferiority for Measlesp-value: <0.00195% CI: [-2.82, 2.25]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for Mumpsp-value: <0.00195% CI: [-0.12, 6.4]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for Rubellap-value: <0.00195% CI: [-1.5, 2.34]Miettinen & Nurminen
Comparison: Difference in percentages: Non-inferiority for Varicellap-value: <0.00195% CI: [-2.11, 2.06]Miettinen & Nurminen
Secondary
Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old
Ab titres were measured by ELISA, excepting the Ab to varicella which was determined by glycoprotein ELISA. Percentage of participants with an Ab titre ≥255 mIU/mL for measles, ≥10 Ab units/mL for mumps, ≥10 IU/mL for rubella, and ≥5 gpELISA units/mL for varicella are reported. 95% CI were calculated based on the exact binomial method by Clopper and Pearson. The immune response to ProQuad vaccine was considered as acceptable if the lower bounds of the 2-sided 95% CI for the response rates were greater than the predetermined lower CI limits: 90% for measles, mumps & rubella, and 76% for varicella.
Time frame: One month after Toddler dose of PRI5 (13 months old)
Population: All participants in the PR5I group who met inclusion criteria, were not protocol violators, received vaccinations within acceptable day ranges, and who had serology results within RW of Days 28 to 51 Post-Toddler dose. Participants from site 0048 were excluded. Participants in the INFANRIX™ hexa group were not analyzed for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Measles ≥255 mIU/mL | 96.15 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Mumps ≥10 Ab units/mL | 94.86 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Rubella ≥10 IU/mL | 98.29 Percentage of participants |
| PR5I | Percentage of Participants Vaccinated With PR5I With Acceptable Ab Response to Measles, Mumps, Rubella and Varicella One Month After the Toddler Dose of ProQuad at 13 Months Old | Anti-Varicella ≥5 gpELISA units/mL | 97.64 Percentage of participants |
Secondary
Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination
Global safety was assessed by measuring injection-site and systemic AEs reported daily on the Vaccination Report Card (VRC) by the parent(s) or legal representative from Day 1 to Day 15 (D1-D15) after each hexavalent vaccination. Solicited injection-site and systemic AEs were reported daily from Day 1 to Day 5 (D1-D5) after each hexavalent vaccination. AEs at injection sites were always considered as vaccine-related (Injection-Site Reactions (ISRs)). The investigator assessed whether systemic AEs were related (V-related) or not to the vaccine. All AEs (related and unrelated) are reported.
Time frame: Day 1 to Day 15 after any vaccination
Population: All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 ISR or systemic AE (D1-D15) | 98.9 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 ISR or V-related systemic AE (D1-D15) | 98.5 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 ISR (D1-D15) | 92.1 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 solicited ISR (D1-D5) | 90.8 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 systemic AE (D1-D15) | 98.4 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 V-related systemic AE (D1-D15) | 95.6 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 solicited systemic AE (D1-D5) | 97 Percentage of participants |
| PR5I | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 V-related solicited systemic AE (D1-D5) | 94.9 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 V-related solicited systemic AE (D1-D5) | 96.2 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 ISR or systemic AE (D1-D15) | 99.5 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 systemic AE (D1-D15) | 99.3 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 ISR or V-related systemic AE (D1-D15) | 98.8 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 solicited systemic AE (D1-D5) | 98.5 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 ISR (D1-D15) | 91.0 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 V-related systemic AE (D1-D15) | 96.5 Percentage of participants |
| INFANRIX™ Hexa | Percentage of Participants With Injection-site and Systemic Adverse Events (AEs) From Day 1 to Day 15 After Any Vaccination | At least 1 solicited ISR (D1-D5) | 89.9 Percentage of participants |
Comparison: Risk difference: ISRs or systemic AEs95% CI: [-1.9, 0.4]
Comparison: Risk difference: ISRs or vaccine-related systemic AEs95% CI: [-1.8, 1.1]
Comparison: Risk difference: At least 1 ISR95% CI: [-2.1, 4.3]
Comparison: Risk difference: At least 1 solicited ISR95% CI: [-2.4, 4.3]
Comparison: Risk difference: At least 1 systemic AE95% CI: [-2.4, 0.3]
Comparison: Risk difference: At least 1 vaccine-related systemic AE95% CI: [-3.2, 1.3]
Comparison: Risk difference: At least 1 solicited systemic AE95% CI: [-3.3, 0.2]
Comparison: Risk difference: At least 1 vaccine-related solicited systemic AE95% CI: [-3.7, 1.1]