CompletedNCT00630331Updated May 24, 2024Results posted

Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

A Phase 3 interventional study of Cell culture-derived influenza vaccine and Egg-derived influenza virus vaccine in Influenza, sponsored by Novartis Vaccines. Completed at 56 sites in 3 countries. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-24.

Sponsored by Novartis Vaccines · Phase 3, Interventional, and Prevention

Phase: Phase 3
Study type: Interventional
Enrollment: 11,404
Allocation: Randomized
Ages: 18 Years to 49 Years
Sex: All

Study summary

The present study will evaluate clinical efficacy, safety, tolerability and immunogenicity of both Novartis Vaccines' cell-derived influenza vaccine and egg-derived influenza vaccine in healthy adults 18 to 49 years of age.

Conditions studied

Influenza

Browse trials for

Influenza, Human 2,214

Keywords

Influenza
Flu
Cell Culture-Derived
Egg-Derived
Healthy Adults
Efficacy
Safety
Immunogenicity
Trivalent
Inactivated
Influenza-Like Illness
Vaccination

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.

This study's enrollment of 11,404 is above the median of 238 across 1,853 interventional studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 49 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

subjects 18 to 49 years of age;
in good health as determined by medical history and physical examination;
able and willing to provide written informed consent prior to any study procedure;
able to comply with all study procedures, including availability and willingness to be actively followed throughout the ensuing influenza season with weekly telephone calls and to comply with the need for prompt collection of nasal and throat specimens in the event of influenza symptoms.

Exclusion criteria

Exclusion Criteria:

history of anaphylaxis or serious reaction after administration of any vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, kanamycin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
any health condition for which the inactivated vaccine is recommended by the Advisory Committee on Immunization Practices (ACIP) including chronic diseases of the pulmonary or cardiovascular systems (including asthma), chronic metabolic diseases (including diabetes), renal dysfunction, hemoglobinopathies, immune deficiency disease (including HIV infection) or on-going immunosuppressive therapy;
employment in professions prone to influenza transmission to or from high-risk populations (this exclusion specifically includes nurses, physicians, all other healthcare workers with direct patient contact; and police, fire, and rescue personnel); or living in the same household as an immunocompromised person;
history of Guillain-Barré syndrome;
bleeding diathesis;
receipt of another investigational agent within 90 days prior to enrollment in the study or before completion of the safety follow-up period in another study, whichever is longer, and unwilling to refuse participation in another clinical study through the end of the study;
receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
laboratory-confirmed influenza disease within 6 months prior to Visit 1;
receipt of an influenza vaccine within 6 months prior to Visit 1 or plans to receive influenza vaccine outside of this study;
experienced a temperature (≥100.0°F / ≥37.8°C) and/or any acute illness within 3 days prior to study vaccination;
pregnant or breast-feeding female;
if female of childbearing potential and sexually active, has not used any of the birth control methods detailed in the section entitled "Females of Childbearing Potential" for at least 2 months prior to study entry;
if female of childbearing potential and sexually active, refusal to use a reliable contraceptive method as detailed in the section entitled "Females of Childbearing Potential" during the first 3 weeks after vaccination;
research staff directly involved with the clinical study or family members or household members of research staff. Research staff are individuals with direct or indirect contact with study subjects, or study site personnel who have access to any study documents containing subject information. This would include receptionists, persons scheduling appointments or making screening calls, regulatory specialists, laboratory technicians, etc.;
any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives or with the safety of the study subject.

Study design

Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 11,404 participants (actual)

Study arms

Experimental
CCI
Subjects received one dose of cell culture-derived influenza vaccine.
Biological: Cell culture-derived influenza vaccine
Experimental
IVV
Subjects received one dose of the trivalent egg-derived influenza vaccine.
Biological: Egg-derived influenza virus vaccine
Placebo comparator
Placebo
Subjects received one dose of phosphate buffered solution (PBS).
Biological: Placebo

Interventions

BiologicalCell culture-derived influenza vaccine
One dose (0.5 mL) of cell culture-derived influenza vaccine, administered in the deltoid muscle.
BiologicalEgg-derived influenza virus vaccine
One dose (0.5 mL) of the trivalent egg-derived influenza virus vaccine, administered in the deltoid muscle.
BiologicalPlacebo
One dose (0.5 mL) of phosphate buffered solution.

What researchers measure

Primary outcomes

Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains
The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.
Time frame: 6 Months

Secondary outcomes

Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains
The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.
Time frame: 6 Months
Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains
The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.
Time frame: 6 Months
Influenza-Associated Days in Bed, All Subjects
The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Time frame: 6 Months
Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza
The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Time frame: 6 Months
Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects
The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Time frame: 6 Months
Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza
The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Time frame: 6 Months
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects
The number of subjects in this analysis included all subjects in the per protocol efficacy population.
Time frame: 6 Months
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza
The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.
Time frame: 6 Months
Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.
Time frame: Before vaccination (day 1) and three weeks after vaccination (day 22)
Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.
Time frame: Three weeks after vaccination (day 22)
Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.
Time frame: Up to 7 days post vaccination

Results

Posted Jan 16, 2013

Participant flow

Participants were enrolled at multiple centres in the US, Poland and Finland.

Participant flow — Overall Study
Milestone	CCI Vaccine	IVV Vaccine	Placebo
Started	3828	3676	3900
Completed	3622	3510	3712
Not completed	206	166	188
Withdrew: Death	2	1	1
Withdrew: Adverse event	1	0	0
Withdrew: Withdrawal by subject	12	7	5
Withdrew: Lost to follow-up	175	143	170
Withdrew: Inappropriate enrollment	3	6	3
Withdrew: Unable to classify	9	4	3
Withdrew: Protocol violation	4	5	6

Outcome measures

PrimaryNumber of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains

The vaccine efficacy of CCI and IVV vaccines was estimated relative to Placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza illness caused by each of three vaccine-like virus strains.

Time frame:: 6 Months
Reported as:: Number · Subjects

Number of Subjects With Culture-Confirmed Influenza Illness Caused by Vaccine-like Strains
Subjects	CCI Vaccine	IVV Vaccine	Placebo
Overall	7	9	44
A/Wisconsin/67/2005 (H3N2)-like	2	1	0
A/Solomon Islands/3/2006 (H1N1)-like	5	8	43
B/Malaysia/2506/2004-like	0	0	1

Statistical analysis

CCI Vaccine vs Placebo · Sidak-corrected score CI · p = <0.001 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 83.8
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = <0.001 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 88.2
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.999 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.)For strain A/H3N2, the vaccine efficacy of the CCI vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.394 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 100
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.004 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 78.4
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.002 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 80.3
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.992 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.)For strain A/H3N2, the vaccine efficacy of the IVV vaccine vs. placebo was not evaluable since no influenza case was observed in the placebo group.
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.400 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 100

SecondaryNumber of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains

The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo group as the number of subjects prevented against virus-confirmed symptomatic influenza A or B illness caused by non-vaccine-like strains.

Time frame:: 6 Months
Reported as:: Number · Subjects

Number of Subjects With Culture-confirmed Influenza Illness Caused by Non-Vaccine Like Strains
Subjects	CCI Vaccine	IVV Vaccine	Placebo
Overall	30	29	74
A/H3N2	0	2	8
A/H1N1	1	0	8
B	29	27	59

Statistical analysis

CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.078 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 58.7
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.104 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 87.3
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.030 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 100
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.376 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 50.0
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.085 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 58.6
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.033 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 100
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.265 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 73.6
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.319 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 51.7

SecondaryNumber of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains

The vaccine efficacy of CCI and IVV vaccines was estimated relative to placebo as the number of subjected prevented against virus-confirmed symptomatic influenza A or B illness caused by vaccine-like and non-vaccine-like strains.

Time frame:: 6 Months
Reported as:: Number · Subjects

Number of Subjects With Influenza Caused by Vaccine-like and Non-vaccine-like Strains
Subjects	CCI Vaccine	IVV Vaccine	Placebo
Overall	42	49	140
A/H3N2	6	12	25
A/H1N1	6	10	57
B	30	27	61

Statistical analysis

CCI Vaccine vs Placebo · Sidak-corrected score CI · p = <0.001 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 69.5
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = <0.001 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 89.3
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.040 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 75.6
CCI Vaccine vs Placebo · Sidak-corrected score CI · p = 0.37 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of CCI vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 49.9
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.003 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 63.0
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = <0.001 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 81.5
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.53 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 49.3
IVV Vaccine vs Placebo · Sidak-corrected score CI · p = 0.26 (Adjusted p-values are from score statistic with Sidak correction testing the null hypothesis that the VE of IVV vs. placebo is \<= 40% (the relative risk, \>= 0.60). If adjusted p-value is \<0.025, then the comparison is statistically significant.) · Vaccine efficacy: 53.2

SecondaryInfluenza-Associated Days in Bed, All Subjects

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Time frame:: 6 Months
Reported as:: Mean · Number of Days

Influenza-Associated Days in Bed, All Subjects
Number of Days	CCI Vaccine	IVV Vaccine	Placebo
Influenza-Associated Days in Bed, All Subjects	0.04 ± 0.496	0.04 ± 0.404	0.12 ± 0.777

SecondaryInfluenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Time frame:: 6 Months
Reported as:: Mean · Number of Days

Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza
Number of Days	CCI Vaccine	IVV Vaccine	Placebo
Influenza-Associated Days in Bed, Subset of Subjects With Virus-Confirmed- Influenza	3.9 ± 2.62	2.9 ± 1.98	3.4 ± 2.4

SecondaryNumber Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Time frame:: 6 Months
Reported as:: Mean · Number of Medical Visits

Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects
Number of Medical Visits	CCI Vaccine	IVV Vaccine	Placebo
Number Of Medical Visits (Inpatient and Outpatient) Due to Influenza Illness or Symptoms of Influenza, All Subjects	0.01 ± 0.138	0.01 ± 0.134	0.03 ± 0.262

SecondaryNumber of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Time frame:: 6 Months
Reported as:: Mean · Number of Medical Visits

Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza
Number of Medical Visits	CCI Vaccine	IVV Vaccine	Placebo
Number of Medical Visits (Inpatient and Outpatient), Subset of Subjects With Virus-Confirmed-Influenza	0.8 ± 0.92	0.6 ± 1.0	0.8 ± 1.16

SecondaryNumber of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects

The number of subjects in this analysis included all subjects in the per protocol efficacy population.

Time frame:: 6 Months
Reported as:: Mean · Numebr of Days of Usual Activity Lost

Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects
Numebr of Days of Usual Activity Lost	CCI Vaccine	IVV Vaccine	Placebo
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost Due to Influenza Disease, All Subjects	0.06 ± 0.635	0.05 ± 0.605	0.16 ± 1.006

SecondaryNumber of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza

The analysis was done among the subset of subjects in the per protocol efficacy population who had culture-confirmed influenza.

Time frame:: 6 Months
Reported as:: Mean · Numebr of Days of Usual Activity Lost

Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza
Numebr of Days of Usual Activity Lost	CCI Vaccine	IVV Vaccine	Placebo
Number of Days of Usual Activity (i.e. Job, School,Household/Family/Community Activities) Lost, Subset of Subjects With Virus-Confirmed-Influenza	5.1 ± 3.41	4.0 ± 3.4	4.6 ± 3.45

SecondaryPercentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo

Immunogenicity was measured as the percentage of subjects achieving HI titers ≥40 at baseline (day 1) and three weeks after (day 22) one vaccination of either cell-culture or egg-derived vaccine or placebo for each of the three influenza vaccine strains (A/H1N1, A/H3N2 and B), evaluated using hemagglutination inhibition (HI) egg-derived antigen assay. This criterion is met according to US (CBER) guideline if the lower limit of the two-sided 95% CI for the percentage of subjects achieving HI titers ≥40 is ≥70%.

Time frame:: Before vaccination (day 1) and three weeks after vaccination (day 22)
Reported as:: Number · Percentages of subjects

Percentages of Subjects Who Achieved HI Titers ≥40 After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Percentages of subjects	CCI Vaccine	IVV Vaccine	Placebo
A/H1N1 - Day 1	48 (42 to 55)	53 (49 to 57)	60 (46 to 73)
A/H1N1 - Day 22	99 (97 to 100)	98 (97 to 99)	60 (46 to 73)
A/H3N2 - Day 1	63 (57 to 69)	58 (54 to 61)	71 (57 to 82)
A/H3N2 - Day 22	99 (97 to 100)	99 (98 to 100)	65 (51 to 78)
B - Day 1	25 (20 to 31)	23 (20 to 27)	22 (12 to 35)
B - Day 22	78 (72 to 83)	92 (90 to 94)	22 (12 to 35)

SecondaryPercentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo

As per the CBER guideline, seroconversion is defined as the percentage of subjects with a prevaccination HI titer \<10, a postvaccination titer ≥40; or in subjects with prevaccination HI titer ≥10, a ≥4-fold increase in postvaccination HI antibody titer. According to CBER criteria, the lower limit of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody titer at day 22 met exceeded 40%.

Time frame:: Three weeks after vaccination (day 22)
Reported as:: Number · Percentages of subjects

Percentages of Subjects Achieving Seroconversion After One Vaccination of Either Cell-culture Derived or Egg-derived Influenza Vaccine or Placebo
Percentages of subjects	CCI Vaccine	IVV Vaccine	Placebo
A/H1N1	78 (72 to 83)	75 (71 to 78)	0 (0 to 6)
A/H3N2	59 (53 to 66)	68 (64 to 71)	0 (0 to 6)
B	51 (45 to 58)	68 (65 to 72)	0 (0 to 6)

SecondaryNumber of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination

The solicited local and systemic reactogenicity were collected up to 7 days after vaccination for all three vaccine groups.

Time frame:: Up to 7 days post vaccination
Reported as:: Number · Subjects

Number of Subjects Reported Solicited Local and Systemic Reactions up to 7 Days After Vaccination
Subjects	CCI Vaccine	IVV Vaccine	Placebo
Injection site Pain	1158	893	375
Injection site Erythema	510	492	391
Injection site Induration	239	207	101
Injection site Ecchymosis	143	110	147
Injection site Swelling	218	181	103
Chills	210	211	223
Malaise	290	259	237
Myalgia	450	364	275
Arthralgia	108	111	125
Headache	564	551	592
Sweating	124	122	120
Fatigue	390	404	384
Fever (>= 38 C)	27	21	15
Oral Temp. (< 38 C)	3786	3648	3879
Stayed home due to Reactions (N=3781, 3651, 3867)	42	62	42
Analgesic medicines used	394	397	386

Adverse events

Collected over Serious Adverse Events were collected throughout the study period (i.e., 6 months).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
CCI Vaccine	—	42/3,813 (1.1%)	1,949/3,813 (51.1%)
IVV Vaccine	—	35/3,669 (1%)	1,703/3,669 (46.4%)
Placebo	—	38/3,894 (1%)	1,387/3,894 (35.6%)

Most frequent serious events

Showing 10 of 111

Most frequent serious events
Event	CCI Vaccine	IVV Vaccine	Placebo
AppendicitisInfections and infestations	1/3813	1/3669	3/3894
Haemorrhagic Ovarian CystReproductive system and breast disorders	0/3813	2/3669	0/3894
Nasal Septum DeviationRespiratory, thoracic and mediastinal disorders	1/3813	2/3669	0/3894
Ankle FractureInjury, poisoning and procedural complications	2/3813	0/3669	1/3894
Intervertebral Disc ProtrusionMusculoskeletal and connective tissue disorders	2/3813	0/3669	2/3894
PharyngitisInfections and infestations	0/3813	0/3669	2/3894
PneumoniaInfections and infestations	0/3813	1/3669	2/3894
Back PainMusculoskeletal and connective tissue disorders	0/3813	0/3669	2/3894
Vertigo PositionalEar and labyrinth disorders	0/3813	1/3669	0/3894
Abdominal PainGastrointestinal disorders	1/3813	1/3669	0/3894

Most frequent other events

Most frequent other events
Event	CCI Vaccine	IVV Vaccine	Placebo
Injection Site PainGeneral disorders	1158/3813	893/3669	375/3894
HeadacheNervous system disorders	571/3813	554/3669	597/3894
Injection Site ErythemaGeneral disorders	510/3813	492/3669	391/3894
MyalgiaMusculoskeletal and connective tissue disorders	451/3813	369/3669	278/3894
FatigueGeneral disorders	390/3813	404/3669	386/3894
MalaiseGeneral disorders	290/3813	260/3669	238/3894
Injection Site IndurationGeneral disorders	239/3813	207/3669	101/3894
ChillsGeneral disorders	212/3813	212/3669	225/3894
Injection Site SwellingGeneral disorders	218/3813	181/3669	103/3894

Baseline characteristics

Age, Continuous
Age, Continuous(years)	CCI Vaccine	IVV Vaccine	Placebo	Total
Mean	32.7 ± 10.1	33.0 ± 10.2	32.7 ± 10.2	32.8 ± 10.2

Sex/Gender, Customized
Sex/Gender, Customized(Subjects)	CCI Vaccine	IVV Vaccine	Placebo	Total
Female	2088	2026	2176	6290
Male	1740	1649	1722	5111
Not Available	0	1	2	3

Study locations

56 sites

Site 14
Denver, Colorado 80212, United States
Site 15
Pembroke Pines, Florida 33024, United States
Site 17
South Miami, Florida 33143, United States
Site 13
Lenexa, Kansas 66219, United States
Site 2
Bardstown, Kentucky 40004, United States
Site 1
Saint Louis, Missouri 63140, United States
Site 4
Edison, New Jersey 08817, United States
Site 10
Binghamton, New York 13901, United States
Site 5
Endwell, New York 13760, United States
Site 16
Winston-Salem, North Carolina 27103, United States
Site 11
Warwick, Rhode Island 02886, United States
Site 12
Anderson, South Carolina 29621, United States
Site 9
Austin, Texas 78705, United States
Site 8
Dallas, Texas 75234, United States
Site 7
Salt Lake City, Utah 84109, United States
Site 3
Salt Lake City, Utah 84121, United States
Site 6
Burke, Virginia 22105, United States
Site 25
Espoo, 02100, Finland
Site 26
Helsinki, 00100, Finland
Site 27
Helsinki, 00930, Finland
Site 33
Järvenpää, 04400, Finland
Site 35
Kokkola, 67100, Finland
Site 34
Kotka, 48600, Finland
Site 30
Kuopio, 70100, Finland
Site 22
Lahti, 15140, Finland
Site 31
Oulu, 90100, Finland
Site 23
Pori, 28120, Finland
Site 32
Seinäjoki, 60100, Finland
Site 21
Tampere, 33100, Finland
Site 24
Turku, 20520, Finland
Site 28
Vantaa, 01300, Finland
Site 29
Vantaa, 01600, Finland
Site 49
Bydgoszcz, 85-316, Poland
Site 53
Gniewkowo, 88-140, Poland
Site 59
Katowice, 40-084, Poland
Site 63
Kielce, 25-711, Poland
Site 62
Końskie, 26-200, Poland
Site 57
Krakow, 30-510, Poland
Site 41
Kraków, 30-969, Poland
Site 43
Kraków, 31-115, Poland
Site 42
Kraków, 31-503, Poland
Site 50
Kraków, 31-832, Poland
Site 44
Lubartów, 21 - 100, Poland
Site 45
Lublin, 20-044, Poland
Site 65
Oleśnica, 56-400, Poland
Site 47
Olsztyn, 10-117, Poland
Site 48
Olsztyn, 10-295, Poland
Site 46
Olsztyn, 10-461, Poland
Site 58
Radziszów, 32-052, Poland
Site 61
Ruda Śląska, 41-703, Poland
Site 60
Rzeszów, 35-324, Poland
Site 52
Warszawa, 02-777, Poland
Site 55
Wilkowice, 43-365, Poland
Site 64
Wrocław, 51-312, Poland
Site 54
Wąbrzeźno, 87-200, Poland
Site 51
Łodź, 90-302, Poland

References and documents

Publications

Frey S, Vesikari T, Szymczakiewicz-Multanowska A, Lattanzi M, Izu A, Groth N, Holmes S. Clinical efficacy of cell culture-derived and egg-derived inactivated subunit influenza vaccines in healthy adults. Clin Infect Dis. 2010 Nov 1;51(9):997-1004. doi: 10.1086/656578. PubMed 20868284 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00630331
Lead sponsor: Novartis Vaccines
Responsible party: Sponsor
First posted: Mar 7, 2008
Start date: Oct 2007
Primary completion: Jul 2008
Completion: Jul 2008
Results posted: Jan 16, 2013
Last update: May 24, 2024

Study contacts

Novartis Vaccines

study chair · Novartis Vaccines

View the source record on ClinicalTrials.gov ↗

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Efficacy Study of Two Influenza Vaccines and Placebo in Healthy Adult Subjects

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