Measles, Meningococcal Meningitis, Mumps, Rubella, Varicella
Conditions
Keywords
Menactra® vaccine, Meningococcal meningitis, Measles, Mumps, Rubella, Varicella virus, Haemophilus influenzae type b, Pneumococcal conjugate vaccine
Brief summary
This clinical trial will evaluate the safety of two injections of Menactra® Vaccine in subjects at 9 months and at 12 months of age when the second dose is given concomitantly with other pediatric vaccines routinely administered in the US. Safety Objective: To describe the safety profile of two doses of Menactra® Vaccine.
Interventions
BIOLOGICALMeasles-mumps-rubella-varicella vaccine
0.5 mL, intramuscular at 12 months of age
0.5 mL, IM at age 9 and 12 months
BIOLOGICALRoutine paediatric vaccine - Pneumococcal conjugate (PCV)
0.5 mL, Intramuscular at age 12 months
BIOLOGICALRoutine paediatric vaccine - Hepatitis A
0.5 mL, Intramuscular at age 12 months
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 12 Months
Healthy volunteers
Yes
Inclusion criteria
: * Healthy, as determined by medical history and physical examination * Aged 9 months (249 to 305 days) or 12 months (365 to 400 days) at the time of enrollment * The parent or legal guardian has signed and dated the Independent Ethics Committee (IEC)-/Institutional Review Board (IRB)-approved informed consent form.
Exclusion criteria
: * Serious acute or chronic disease (e.g., cardiac, renal, metabolic, rheumatologic, psychiatric, hematologic, autoimmune disorders, diabetes, atopic conditions, congenital defects, convulsions, encephalopathy, blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic system, acute untreated tuberculosis) that could interfere with trial conduct or completion. * Known or suspected impairment of immunologic function. * Acute medical illness within the last 72 hours or a temperature ≥ 100.4ºF (≥ 38.0ºC) at the time of enrollment. * History of documented invasive meningococcal disease or previous meningococcal vaccination. * Has received the fourth dose of Prevnar, or the first dose of measles-mumps-rubella (MMR), varicella, or hepatitis A (HepA) vaccine. * Known human immunodeficiency virus (HIV), hepatitis B, or hepatitis C seropositivity as reported by the parent or legal guardian. * Received either immune globulin or other blood products within the last 3 months. * Suspected or known hypersensitivity to any of the vaccine components. * Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination. * Parent or legal guardian unable or unwilling to comply with the study procedures. * Participation in another interventional clinical trial in the 30 days preceding enrollment, or participation in another clinical trial involving the investigation of a drug, vaccine, medical procedure, or medical device during the subject's trial period. * Diagnosed with any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine. * Received any vaccine in the 30-day period prior to receipt of the study vaccine(s), or scheduled to receive any vaccination other than influenza vaccination and hyposensitization therapy in the 30-day period after receipt of the study vaccine(s). * Personal or family history of Guillain-Barré Syndrome (GBS). * History of seizures, including febrile seizures, or any other neurologic disorder. * Known hypersensitivity to dry natural rubber latex. For the subjects scheduled to provide blood samples: \- Anticipated to receive oral or injected antibiotic therapy within the 72 hours prior to either of the study blood draws. Topical antibiotics and antibiotic drops are not included in this exclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Day 0 to 7 Post-vaccination | Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability |
Other
| Measure | Time frame |
|---|---|
| Safety Overview After Any Vaccination in Participants Who Received MMR+V | Day 0 to 7 Post-vaccination |
Countries
Chile, United States
Participant flow
Recruitment details
Participants were enrolled from 30 May 2007 to 28 March 2008 at 82 US clinical centers.
Pre-assignment details
A total of 1378 participants met inclusion and exclusion criteria, of which 1374 were vaccinated and included in this analysis.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Menactra and Routine Pediatric Vaccines Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | 1,053 |
| Group 2: Routine Pediatric Vaccines Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively) | 321 |
| Total | 1,374 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 6 | 0 |
| Overall Study | Lost to Follow-up | 16 | 4 |
| Overall Study | Protocol Violation | 28 | 9 |
| Overall Study | Withdrawal by Subject | 52 | 0 |
Baseline characteristics
| Characteristic | Group 2: Routine Pediatric Vaccines | Group 1: Menactra and Routine Pediatric Vaccines | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 321 Participants | 1053 Participants | 1374 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 374.6 Days STANDARD_DEVIATION 8.93 | 282.8 Days STANDARD_DEVIATION 10.79 | 304.3 Days STANDARD_DEVIATION 40.22 |
| Region of Enrollment United States | 321 participants | 1053 participants | 1374 participants |
| Sex: Female, Male Female | 158 Participants | 511 Participants | 669 Participants |
| Sex: Female, Male Male | 163 Participants | 542 Participants | 705 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 530 / 1,053 | 95 / 321 |
| serious Total, serious adverse events | 42 / 1,053 | 5 / 321 |
Outcome results
Primary
Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination.
Solicited injection site reactions: tenderness, Erythema (Redness), and Swelling. Solicited systemic reactions: Fever (Temperature), Vomiting, Crying Abnormal, Drowsiness, Appetite Lost, and Irritability
Time frame: Day 0 to 7 Post-vaccination
Population: Safety analysis was on all enrolled and vaccinated participants with available reaction data, intent-to-treat population. Data on 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines were analyzed separately.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - PCV | 20 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 9 Months - Menactra | 30 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months, HepA | 50 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - HepA | 43 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - Menactra | 16 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - HepA | 25 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months, MMRV | 44 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - HepA | 16 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 9 Months - Menactra | 52 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - MMRV | 39 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Systemic Reaction at 9 Months | 69 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 9 Months - Menactra | 17 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Fever, (rectal or oral temperature route) | 12 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Irritability (Inconsolable) | 3 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - MMRV | 23 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Crying Abnormal at 9 Months | 33 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Drowsiness at 9 Months | 30 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 9 Months - Menactra | 37 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - MMRV | 12 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Appetite Lost at 9 Months | 30 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months -Menactra | 58 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Solicited Systemic Reaction at 12 Months | 73 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Fever, (rectal or oral temperature route) | 25 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Irritability at 9 Months | 57 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route | 2 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months, PCV | 53 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Vomiting at 12 Months | 11 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - Menactra | 49 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Crying Abnormal at 12 Months | 40 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - PCV | 46 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 2 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Drowsiness at 12 Months | 40 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 2 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 1 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Appetite Lost at 12 Months | 36 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - PCV | 29 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 3 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Vomiting at 9 Months | 14 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Irritability at 12 Months | 62 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Irritability (Inconsolable) | 4 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - Menactra | 30 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - HepA | 14 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Vomiting at 9 Months | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Irritability at 9 Months | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Irritability (Inconsolable) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Vomiting at 12 Months | 10 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 9 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 9 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 9 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 9 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months -Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - Menactra | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months, MMRV | 59 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - MMRV | 43 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - MMRV | 33 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - MMRV | 14 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months, PCV | 56 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - PCV | 46 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - PCV | 33 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 1 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Swelling at 12 Months - PCV | 17 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 1 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Injection Site Reaction at 12 Months, HepA | 52 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Tenderness at 12 Months - HepA | 41 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Tenderness (Cries when limb is moved) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Erythema at 12 Months - HepA | 27 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Erythema (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | NA Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Swelling (≥ 2.0 in [≥ 5.0 cm]) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Systemic Reaction at 9 Months | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Fever, (rectal or oral temperature route) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Crying Abnormal at 9 Months | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Drowsiness at 9 Months | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Drowsiness (Sleeps most of time) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Appetite Lost at 9 Months | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Solicited Systemic Reaction at 12 Months | 75 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Fever, (rectal or oral temperature route) | 22 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Fever (>103.1 ºF [>39.5 ºC]), Any Route | 3 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Vomiting (≥ 6 episodes per 24 hours) | 0 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Crying Abnormal at 12 Months | 39 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Crying Abnormal (> 3 hours) | 1 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Drowsiness at 12 Months | 39 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Drowsiness (Sleeps most of time) | 1 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Appetite Lost at 12 Months | 32 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Appetite Lost (Refuses ≥ 3 feeds/meals) | 1 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Any Irritability at 12 Months | 65 Percentage of participants |
| Group 2: Routine Pediatric Vaccines | Percentage of Participants With at Least One Solicited Injection Site Reaction or Systemic Reaction Following Vaccination. | Grade 3 Irritability (Inconsolable) | 4 Percentage of participants |
Other Pre-specified
Safety Overview After Any Vaccination in Participants Who Received MMR+V
Time frame: Day 0 to 7 Post-vaccination
Population: Summary of the safety analysis of the 23 participants in Group 1 that received MMR+V vaccines instead of a MMRV single vaccine in addition to the PCV and HepA vaccines.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Injection Site Reaction at 9-Month, Menactra | 44 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Injection Site Reaction at 12-Month, Menactra | 57 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Injection Site Reaction at 12-Month, MMR | 52 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Injection Site Reaction at 12-Month, Varivax | 41 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Injection Site Reaction at 12-Month, PCV | 68 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Injection Site Reaction at 12-Month, HepA | 65 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Any Solicited Systemic Reaction at 9-Month vac | 52 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Any Solicited Systemic Reaction at 12-Month vac | 70 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Unsolicited Adverse Event at 9-Month | 52 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Unsolicited Adverse Event at 12-Month | 36 Percentage of participants |
| Group 1: Menactra and Routine Pediatric Vaccines | Safety Overview After Any Vaccination in Participants Who Received MMR+V | Serious Adverse Events | 0 Percentage of participants |