Vaccine Information: Influenza A (H1N1) 2009 Monovalent Vaccine

INFLUENZA A (H1N1) 2009 MONOVALENT VACCINE- influenza a virus a/california/7/2009(h1n1)-like hemagglutinin antigen (propiolactone inactivated) injection, suspension
Novartis Vaccines and Diagnostics Ltd

1 Indications and Usage

Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for immunization of persons 4 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

2 Dosage and Administration

2.1 Preparation for Administration

Inspect Influenza A (H1N1) 2009 Monovalent Vaccine syringes and multidose vials visually for particulate matter and/or discoloration prior to administration. If either of these conditions exists, the vaccine should not be administered.

Shake the syringe vigorously before administering the vaccine and shake the multidose vial preparation each time before withdrawing a dose of vaccine.

Between uses, return the multidose vial to the recommended storage conditions between 2º and 8ºC (36º and 46ºF). Do not freeze. Discard if the vaccine has been frozen.

A separate syringe and needle or a sterile disposable unit should be used for each injection to prevent transmission of infectious agents from one person to another. Needles should be disposed of properly and not recapped.

It is recommended that small syringes (0.5-mL or 1-mL) should be used to minimize any product loss.

2.2 Recommended Dose and Schedule

Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine to determine the optimal dosage, number of doses and schedule.

Available data show that children 9 years of age and younger are largely serologically naïve to the pandemic (H1N1) 2009 virus (15.1). Based upon these data Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as follows:

Children (4 to 17 years of age):

Children 4 through 9 years of age should receive two 0.5mL doses by intramuscular injection approximately 1 month apart.

Children 10 through 17 years of age should receive a single 0.5-mL intramuscular injection.

The needle size may range from 7/8 to 1¼ inches, depending on the size of the child’s deltoid muscle, and should be of sufficient length to penetrate the muscle tissue. The anterolateral thigh can be used, but the needle should be longer, usually 1 inch.

The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.

Adults (18 years of age and older):

Influenza A (H1N1) 2009 Monovalent Vaccine should be administered as a single 0.5-mL intramuscular injection preferably in the region of the deltoid muscle of the upper arm.

A needle of ≥1 inch is preferred because needles <1 inch might be of insufficient length to penetrate muscle tissue in certain adults.

The vaccine should not be injected in the gluteal region or areas where there may be a major nerve trunk.

3 DOSAGE FORMS AND STRENGTHS

Influenza A (H1N1) 2009 Monovalent Vaccine is a sterile suspension for intramuscular injection. [see DESCRIPTION (11) for the complete list of ingredients]

Influenza A (H1N1) 2009 Monovalent Vaccine is available in two presentations:

1) Prefilled single dose syringe, 0.5-mL. Thimerosal, a mercury derivative used during manufacture, is removed by subsequent purification steps to a trace amount (≤ 1 mcg mercury per 0.5-mL dose).

2) Multidose vial, 5-mL. Contains thimerosal, a mercury derivative, added as a preservative. Each 0.5-mL dose from the multidose vial contains 25 mcg mercury.

4 CONTRAINDICATIONS

4.1 Hypersensitivity

Influenza A (H1N1) 2009 Monovalent Vaccine should not be administered to anyone with known systemic hypersensitivity reactions to egg proteins (eggs or egg products), or to any component of Influenza A (H1N1) 2009 Monovalent Vaccine, or who has had a life-threatening reaction to previous influenza vaccinations [see DESCRIPTION (11)].

5 WARNINGS AND PRECAUTIONS

5.1 Guillain-Barré Syndrome

If Guillain-Barré syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine should be based on careful consideration of the potential benefits and risks.

5.2 Altered Immunocompetence

If Influenza A (H1N1) 2009 Monovalent Vaccine is administered to immunocompromised persons, including individuals receiving immunosuppressive therapy, the expected immune response may not be obtained.

5.3 Preventing and Managing Allergic Reactions

Prior to administration of any dose of Influenza A (H1N1) 2009 Monovalent Vaccine, the healthcare provider should review the patient’s prior immunization history for possible adverse events, to determine the existence of any contraindication to immunization with Influenza A (H1N1) 2009 Monovalent Vaccine and to allow an assessment of benefits and risks. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

5.4 Limitations of Vaccine Effectiveness

Vaccination with Influenza A (H1N1) 2009 Monovalent Vaccine may not protect all individuals.

6 ADVERSE REACTIONS

Novartis’ Influenza A (H1N1) 2009 Monovalent Vaccine and seasonal trivalent Influenza Virus Vaccine (FLUVIRIN®) are manufactured by the same process. The data in this section were obtained from clinical studies and postmarketing experience with FLUVIRIN.

6.1 Overall Adverse Reaction Profile

Serious allergic reactions, including anaphylactic shock, have been observed in individuals receiving FLUVIRIN during postmarketing surveillance.

6.2 Clinical Trial Experience

Adverse event information from clinical trials provides a basis for identifying adverse events that appear to be related to vaccine use and for approximating the rates of these events. However, because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine, and may not reflect rates observed in clinical practice.

Adult and Geriatric Subjects

Safety data were collected in a total of 2768 adult and geriatric subjects (18 years of age and older) who have received FLUVIRIN in 29 clinical studies since 1982.

In 9 clinical studies since 1997, among 1261 recipients of FLUVIRIN, 745 (59%) were women; 1211 (96%) were White, 23 (2%) Asian, 15 (1%) Black and 12 (1%) other; 370 (29%) of subjects were elderly (≥65 years of age). All studies have been conducted in the UK, apart from a study run in the US in 2005-2006 where FLUVIRIN was used as a comparator for an unlicensed vaccine.

After vaccination, the subjects were observed for 30 minutes for hypersensitivity or other immediate reactions. Subjects were instructed to complete a diary card for three days following immunization (i.e. Day 1 to 4) to collect local and systemic reactions (see Tables 1 and 2). All local and systemic adverse events were considered to be at least possibly related to the vaccine. Local and systemic reactions mostly began between day 1 and day 2. The overall adverse events reported in clinical trials since 1998 in at least 5% of the subjects are summarized in Table 3.

TABLE 1 Solicited Adverse Events in the First 72-96 Hours after Administration of FLUVIRIN in Adult (18-64 years of age) and Geriatric (≥65 years of age) Subjects.
1998-1999 1999-2000 2000-2001
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 66 N = 44 N = 76 N = 34 N = 75 N = 35

Results reported to the nearest whole percent; Fever defined as >38°C

– not reported

* Solicited adverse events in the first 72 hours after administration of FLUVIRIN

§ Solicited adverse events reported by COSTART preferred term

^ Solicited adverse events reported by MEDDRA preferred term

Local Adverse Events
Pain 16 (24%) 4 (9%) 16 (21%) 9 (12%)
Mass 7 (11%) 1 (2%) 4 (5%) 8 (11%) 1 (3%)
Inflammation 5 (8%) 2 (5%) 6 (8%) 7 (9%) 1 (3%)
Ecchymosis 4 (6%) 1 (2%) 3 (4%) 1 (3%) 4 (5%)
Edema 2 (3%) 1 (2%) 1 (1%) 2 (6%) 3 (4%) 1 (3%)
Reaction 2 (3%) 2 (3%) 4 (5%) 1 (3%)
Hemorrhage 1 (1%)
Systemic Adverse Events
Headache 7 (11%) 1 (2%) 17 (22%) 3 (9%) 4 (5%)
Fatigue 3 (5%) 2 (5%) 4 (5%) 1 (3%) 3 (4%)
Malaise 2 (3%) 1 (2%) 2 (3%) 1 (3%) 1 (1%)
Myalgia 1 (2%) 2 (3%)
Fever 1 (2%) 1 (1%)
Arthralgia 1 (2%) 1 (3%)
Sweating 3 (4%) 1 (1%) 1 (3%)
2001-2002 *^ 2002-2003 *^ 2004-2005* ^
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 75 N = 35 N = 107 N = 88 N = 74 N = 61
Local Adverse Events
Pain 12 (16%) 1 (3%) 14 (13%) 7 (8%) 15 (20%) 9 (15%)
Mass 4 (5%) 1 (3%)
Ecchymosis 2 (3%) 3 (3%) 3 (3%) 2 (3%) 1 (2%)
Edema 2 (3%) 1 (3%) 6 (6%) 2 (2%)
Erythema 5 (7%) 11 (10%) 5 (6%) 16 (22%) 5 (8%)
Swelling 11 (15%) 4 (7%)
Reaction 2 (2%)
Induration 14 (13%) 3 (3%) 11 (15%) 1 (2%)
Pruritus 1 (1%)
Systemic Adverse Events
Headache 8 (11%) 1 (3%) 12 (11%) 9 (10%) 14 (19%) 3 (5%)
Fatigue 1 (1%) 1 (3%) 5 (7%) 2 (3%)
Malaise 3 (4%) 3 (3%) 4 (5%) 1 (1%) 1 (2%)
Myalgia 3 (4%) 5 (5%) 3 (3%) 8 (11%) 1 (2%)
Fever 1 (1%)
Arthralgia 2 (2%) 1 (1%)
Sweating 3 (4%) 1 (3%) 2 (2%)
Shivering 1 (1%)
TABLE 2 Solicited Adverse Events in the First 72 Hours after Administration of FLUVIRIN in Adult Subjects (18-49 years of age).
2005-2006 US Trial
FLUVIRIN
N = 304

Results reported to the nearest whole percent

– not reported

Local Adverse Events
Pain 168 (55%)
Erythema 48 (16%)
Ecchymosis 22 (7%)
Induration 19 (6%)
Swelling 16 (5%)
Systemic Adverse Events
Headache 91 (30%)
Myalgia 64 (21%)
Malaise 58 (19%)
Fatigue 56 (18%)
Sore throat 23 (8%)
Chills 22 (7%)
Nausea 21 (7%)
Arthralgia 20 (7%)
Sweating 17 (6%)
Cough 18 (6%)
Wheezing 4 (1%)
Chest tightness 4 (1%)
Other difficulties breathing 3 (1%)
Facial edema
TABLE 3 Adverse Events Reported by at least 5% of Subjects in Clinical Trials since 1998
1998-1999§ 1999-2000§ 2000-2001§
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 66 N = 44 N = 76 N = 34 N = 75 N = 35

Results reported to the nearest whole percent; Fever defined as >38°C

– not reaching the cut-off of 5%

§ Solicited adverse events reported by COSTART preferred term

^ Solicited adverse events reported by MEDDRA preferred term

Adverse Events
Fatigue 8 (12%) 2 (5%) 8 (11%) 2 (6%) 5 (7%)
Back pain 4 (6%) 3 (7%)
Cough increased 2 (3%) 2 (5%)
Ecchymosis 4 (6%) 1 (2%) 4 (5%) 1 (3%) 5 (7%)
Fever 3 (5%)
Headache 12 (18%) 5 (11%) 22 (29%) 5 (15%) 14 (19%) 2 (6%)
Infection 3 (5%) 2 (5%)
Malaise 4 (6%) 4 (9%) 4 (5%) 1 (3%)
Migraine 4 (6%) 1 (2%)
Myalgia 4 (6%) 1 (2%)
Sweating 5 (8%) 1 (2%)
Rhinitis 3 (5%) 1 (2%) 5 (7%) 2 (6%)
Pharingitis 6 (9%) 1 (2%) 10 (13%) 6 (8%)
Arthralgia 2 (6%)
Injection site pain 16 (24%) 4 (9%) 16 (21%) 9 (12%)
Injection site ecchymosis 4 (6%) 1 (2%) 4 (5%)
Injection site mass 7 (11%) 1 (2%) 4 (5%) 8 (11%) 1 (3%)
Injection site edema 1 (1%) 2 (6%)
Injection site inflammation 5 (8%) 2 (5%) 6 (8%) 7 (9%) 1 (3%)
Injection site reaction 4 (5%) 1 (3%)
2001-2002 ^ 2002-2003 ^ 2004-2005 ^
18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs 18-64 yrs ≥ 65 yrs
N = 75 N = 35 N = 107 N = 88 N = 74 N = 61
Adverse Events
Fatigue 5 (7%) 4 (11%) 11 (10%) 8 (9%) 4 (5%) 2 (3%)
Hypertension 1 (1%) 4 (5%)
Rinorrhea 2 (2%) 5 (6%)
Headache 20 (27%) 2 (6%) 35 (33%) 18 (20%) 12 (16%) 1 (2%)
Malaise 6 (8%) 1 (3%) 13 (12%) 8 (9%)
Myalgia 4 (5%) 1 (3%) 10 (9%) 4 (5%)
Sweating 3 (4%) 3 (9%) 2 (2%) 5 (6%)
Rhinitis 4 (5%)
Pharingitis 6 (8%)
Arthralgia 5 (5%) 4 (5%)
Sore throat 4 (5%) 1 (3%) 5 (5%) 4 (5%)
Injection site pain 13 (17%) 3 (9%) 14 (13%) 7 (8%) 6 (8%) 2 (3%)
Injection site ecchymosis 4 (5%) 1 (3%) 4 (4%) 4 (5%)
Injection site erythema 5 (7%) 2 (6%) 11 (10%) 5 (6%) 4 (5%)
Injection site mass 4 (5%) 1 (3%)
Injection site edema 6 (6%) 2 (2%) 4 (5%) 1 (2%)
Injection site induration 14 (13%) 3 (3%) 7 (9%)

Adults (18 to 64 years of age)

In adult subjects, solicited local adverse events occurred with similar frequency in all trials. The most common solicited adverse events occurring in the first 96 hours after administration (Tables 1 and 2) were associated with the injection site (such as pain, erythema, mass, induration and swelling) but were generally mild/moderate and transient. The most common solicited systemic adverse events were headache and myalgia.

The most common overall events in adult subjects (18-64 years of age) were headache, fatigue, injection site reactions (pain, mass, erythema, and induration) and malaise (Table 3).

Geriatric Subjects (65 years of age and older)

In geriatric subjects, solicited local and systemic adverse events occurred less frequently than in adult subjects. The most common solicited local and systemic adverse events were injection site pain, and headache (Tables 1 and 2). All were considered mild/moderate and were transient.

The most common overall events in elderly subjects (≥65 years of age) were headache and fatigue.

Only 11 serious adverse events in adult and geriatric subjects (18 years and older) have been reported to date from all the trials performed. These serious adverse events were a minor stroke experienced by a 67 year old subject 14 days after vaccination (1990), death of an 82 year old subject 35 days after vaccination (1990) in very early studies; death of a 72 year old subject 19 days after vaccination (1998-1999), a hospitalization for hemorrhoidectomy of a 38 year old male subject (1999-2000), a severe respiratory tract infection experienced by a 74 year old subject 12 days after vaccination (2002-2003), a planned transurethral resection of the prostate in a subject with prior history of prostatism (2004-2005), two cases of influenza (2005-2006), a drug overdose (2005-2006), cholelithiasis (2005-2006) and a nasal septal operation (2005-2006). None of these events were considered causally related to vaccination.

Clinical Trial Experience in Pediatric Subjects

In 1987 a clinical study was carried out in 38 ‘at risk’ children aged between 4 and 12 years (17 females and 21 males). To record the safety of FLUVIRIN, participants recorded their symptoms on a diary card during the three days after vaccination and noted any further symptoms they thought were attributable to the vaccine. The only reactions recorded were tenderness at the site of vaccination in 21% of the participants on day 1, which was still present in 16% on day 2 and 5% on day 3. In one child, the tenderness was also accompanied by redness at the site of injection for two days. The reactions were not age-dependent and there was no bias towards the younger children.

Three clinical studies were carried out between 1995 and 2004 in a total of 520 pediatric subjects (age range 6 — 47 months). Of these, 285 healthy subjects plus 41 ‘at risk’ subjects received FLUVIRIN. No serious adverse events were reported.

FLUVIRIN and Influenza A (H1N1) 2009 Monovalent Vaccine should only be used for the immunization of persons aged 4 years and over.

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