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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021490-37 | EudraCT Number |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PR5I | Experimental | V419 + RotaTeq + Prevenar 13 + ProQuad |
|
| INFANRIX™ hexa | Active Comparator | INFANRIX™ hexa + RotaTeq + Prevenar 13 + ProQuad |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V419 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%). | One month after post-dose 3 of PRI5 (5 months old) |
| 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%). | One month after Toddler dose of PRI5 (13 months old) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27846055 | Derived | Vesikari T, Becker T, Vertruyen AF, Poschet K, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III Randomized, Double-blind, Clinical Trial of an Investigational Hexavalent Vaccine Given at Two, Three, Four and Twelve Months. Pediatr Infect Dis J. 2017 Feb;36(2):209-215. doi: 10.1097/INF.0000000000001406. |
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Healthy infants 46 to 74 days old were enrolled in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Infant Series |
|
| |||||||||||||||||||||||||||
| Interim Period |
| ||||||||||||||||||||||||||||
| Toddler Dose |
| ||||||||||||||||||||||||||||
| Post-Treatment |
|
All randomized participants excluding participants from site 0048.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | INFANRIX™ Hexa |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | One month after post-dose 3 of PRI5 (5 months old) |
2 months after Toddler Dose (up to approximately age 14 months)
All Treated Participants. Participants from site 0048 were excluded.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Benign familial neonatal convulsions | Congenital, familial and genetic disorders | MedDRA 15.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctivitis | Eye disorders | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D014777 | Virus Diseases |
| D004165 | Diphtheria |
| D014917 | Whooping Cough |
| D013742 | Tetanus |
| D006509 | Hepatitis B |
| D006192 | Haemophilus Infections |
| D011051 | Poliomyelitis |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
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| ID | Term |
|---|---|
| C492535 | RotaTeq |
| C538862 | 13-valent pneumococcal vaccine |
| C050102 | measles, mumps, rubella, varicella vaccine |
Not provided
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|
| INFANRIX™ hexa | Biological | INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age. |
|
| RotaTeq | Biological | RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age |
|
| Prevenar 13 | Biological | Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age |
|
| ProQuad™ | Biological | ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age |
|
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. |
| One month after post-dose 3 of PRI5 (5 months old) |
| 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. | One month after Toddler dose of PRI5 (13 months old) |
| One month after Toddler dose of PRI5 (13 months old) |
| 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. | One month after Toddler dose of PRI5 (13 months old) |
| 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. | Day 1 to Day 15 after any vaccination |
| 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)). | Day 1 to Day 5 after any vaccination |
| 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 | Day 1 to Day 15 after any vaccination |
| 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. | Day 1 to Day 5 after any vaccination |
| Adverse Event |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Site 0048 Participants |
|
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| NOT COMPLETED |
|
|
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.
| BG002 | Total | Total of all reporting groups |
| Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
|
| 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%). | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | One month after Toddler dose of PRI5 (13 months old) |
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | One month after post-dose 3 of PRI5 (5 months old) |
|
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | One month after Toddler dose of PRI5 (13 months old) |
|
|
|
|
| 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | One month after Toddler dose of PRI5 (13 months old) |
|
|
|
| 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. | 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. | Posted | Number | Percentage of participants | One month after Toddler dose of PRI5 (13 months old) |
|
|
|
|
| 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. | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Posted | Number | Percentage of participants | Day 1 to Day 15 after any vaccination |
|
|
|
|
| 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)). | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Posted | Number | Percentage of participants | Day 1 to Day 5 after any vaccination |
|
|
|
|
| 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 | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Posted | Number | Percentage of participants | Day 1 to Day 15 after any vaccination |
|
|
|
|
| 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. | All randomised participants who received at least 1 vaccination and who had safety follow-up. Participants from site 0048 were excluded. | Posted | Number | Percentage of participants | Day 1 to Day 5 after any vaccination |
|
|
|
|
| 0 |
| 610 |
| 23 |
| 610 |
| 603 |
| 610 |
| EG001 | 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. | 0 | 605 | 22 | 605 | 599 | 605 |
| Inguinal hernia | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Swollen tongue | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Bronchiolitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Bronchitis viral | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Exanthema subitum | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumococcal sepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Pyelonephritis acute | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory syncytial virus bronchiolitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Skin infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Urosepsis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Abdominal injury | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Skull fracture | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 15.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
| Prolymphocytic leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.1 | Systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Febrile convulsion | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Neuroendocrine cell hyperplasia of infancy | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Crying | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site induration | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Irritability | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 15.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Otitis media | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Systematic Assessment |
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The SPONSOR and SPONSOR representative must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR or SPONSOR representative as confidential must be deleted prior to submission.
| D016908 | Gram-Positive Bacterial Infections |
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
| D003015 | Clostridium Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D016871 | Pasteurellaceae Infections |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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| Anti-Tetanus ≥0.1 IU/mL |
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| Anti-IPV1 ≥8 (1/dil) |
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| Anti-IPV2 ≥8 (1/dil) |
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| Anti-IPV3 ≥8 (1/dil) |
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| Anti-HBsAg ≥10 mIU/mL |
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| Anti-PT seroresponse |
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| Anti-FHA seroresponse |
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| Anti-FIM seroresponse |
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| Anti-PRN seroresponse |
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| Anti-Diphtheria ≥0.01 IU/mL |
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| Anti-Tetanus ≥0.01 IU/mL |
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| Anti-IPV1 ≥8 (1/dil) |
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| Anti-IPV2 ≥8 (1/dil) |
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| Anti-IPV3 ≥8 (1/dil) |
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PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for Diphtheria | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 0 | 2-Sided | 95 | -0.95 | 0.96 | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for Tetanus | Miettinen & Nurminen | < 0.001 | Difference in percentages | 0 | 2-Sided | 95 | -0.71 | 0.74 | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for IPV1 | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 0.19 | 2-Sided | 95 | -0.51 | 1.07 | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for IPV2 | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 0.19 | 2-Sided | 95 | -0.69 | 1.21 | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for IPV3 | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 0 | 2-Sided | 95 | -0.7 | 0.73 | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Anti-PT seroresponse |
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| Anti-FHA seroresponse |
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| Anti-PRN seroresponse |
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PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for PT | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 1.33 | 2-Sided | 95 | 0.32 | 2.86 | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for FHA | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | -2.59 | 2-Sided | 95 | -4.39 | -1.29 | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for PRN | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 0.03 | 2-Sided | 95 | -1.4 | 1.52 | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
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| Anti-Varicella ≥5 gpELISA units/mL |
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| Anti-Mumps ≥10 Ab units/mL |
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| Anti-Rubella ≥10 IU/mL |
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| Anti-Varicella ≥5 gpELISA units/mL |
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PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for Mumps | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 3.07 | 2-Sided | 95 | -0.12 | 6.4 | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for Rubella | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | 0.39 | 2-Sided | 95 | -1.5 | 2.34 | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -5% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| Difference in percentages: Non-inferiority for Varicella | Miettinen & Nurminen | < 0.001 | 1-sided | Difference in percentages | -0.02 | 2-Sided | 95 | -2.11 | 2.06 | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | Non-Inferiority | If the lower bound of the 95% CI was greater than -10% (non-inferiority margin), it was concluded that PR5I group response rate was non-inferior to INFANRIX hexa group response rate. | PR5I minus INFANRIX™ hexa |
| At least 1 ISR or V-related systemic AE (D1-D15) |
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| At least 1 ISR (D1-D15) |
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| At least 1 solicited ISR (D1-D5) |
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| At least 1 systemic AE (D1-D15) |
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| At least 1 V-related systemic AE (D1-D15) |
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| At least 1 solicited systemic AE (D1-D5) |
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| At least 1 V-related solicited systemic AE (D1-D5) |
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Risk difference: ISRs or vaccine-related systemic AEs |
| Risk Difference (RD) |
| -0.3 |
| 2-Sided |
| 95 |
| -1.8 |
| 1.1 |
If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. |
| Other |
Miettinen & Nurminen method |
PR5I minus INFANRIX™ hexa |
| Risk difference: At least 1 ISR | Risk Difference (RD) | 1.1 | 2-Sided | 95 | -2.1 | 4.3 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: At least 1 solicited ISR | Risk Difference (RD) | 0.9 | 2-Sided | 95 | -2.4 | 4.3 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: At least 1 systemic AE | Risk Difference (RD) | -1 | 2-Sided | 95 | -2.4 | 0.3 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: At least 1 vaccine-related systemic AE | Risk Difference (RD) | -0.9 | 2-Sided | 95 | -3.2 | 1.3 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: At least 1 solicited systemic AE | Risk Difference (RD) | -1.5 | 2-Sided | 95 | -3.3 | 0.2 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: At least 1 vaccine-related solicited systemic AE | Risk Difference (RD) | -1.3 | 2-Sided | 95 | -3.7 | 1.1 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Injection-site swelling |
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Risk difference: Injection-site pain |
| Risk Difference (RD) |
| 1.8 |
| 2-Sided |
| 95 |
| -3.2 |
| 6.8 |
If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. |
| Other |
Miettinen & Nurminen method |
PR5I minus INFANRIX™ hexa |
| Risk difference: Injection-site swelling | Risk Difference (RD) | 4 | 2-Sided | 95 | -1.6 | 9.6 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Injection-site haematoma |
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| Injection-site haemorrhage |
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| Injection-site induration |
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| Injection-site nodule |
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| Injection-site warmth |
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Risk difference: Injection-site haematoma |
| Risk Difference (RD) |
| 0.6 |
| 2-Sided |
| 95 |
| -0.6 |
| 2.1 |
If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. |
| Other |
Miettinen & Nurminen method |
PR5I minus INFANRIX™ hexa |
| Risk difference: Injection-site haemorrhage | Risk Difference (RD) | -0.7 | 2-Sided | 95 | -2.3 | 0.8 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: Injection-site induration | Risk Difference (RD) | -3.7 | 2-Sided | 95 | -7.8 | 0.5 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: Injection-site nodule | Risk Difference (RD) | -0.2 | 2-Sided | 95 | -1.7 | 1.3 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: Injection-site warmth | Risk Difference (RD) | 1.1 | 95 | -0.6 | 3 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Irritability |
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| Pyrexia |
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| Somnolence |
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| Vomiting |
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Risk difference: Decreased appetite |
| Risk Difference (RD) |
| -3.1 |
| 2-Sided |
| 95 |
| -8.4 |
| 2.3 |
If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. |
| Other |
Miettinen & Nurminen method |
PR5I minus INFANRIX™ hexa |
| Risk difference: Irritability | Risk Difference (RD) | 2.1 | 2-Sided | 95 | -1.7 | 6 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: Pyrexia | Risk Difference (RD) | -1.7 | 2-Sided | 95 | -6.7 | 3.4 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: Somnolence | Risk Difference (RD) | -3.2 | 2-Sided | 95 | -7.8 | 1.4 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |
| Risk difference: Vomiting | Risk Difference (RD) | 0.8 | 2-Sided | 95 | -4.4 | 6 | If the 95% CI for the risk differences included 0.0, the numerical differences were not considered significant. | Other | Miettinen & Nurminen method | PR5I minus INFANRIX™ hexa |